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Important Surgical Risks

Serious complications may occur with any surgery, including da Vinci Surgery, up to and including death. In addition, there are risks that are specific to certain surgical procedures. Certain pre-existing medical conditions can also increase the risks of any surgery. Surgeons should discuss pertinent surgical risks with their patients.

This document provides a summary of the risks associated with surgery and includes four different sections.

  • Section I includes the negative outcomes, risks and complications of any type of surgery.
  • Section II includes the negative outcomes, risks and complications of minimally invasive surgical techniques.
  • Section III includes the negative outcomes, risks and complications of da Vinci surgery.
  • Section IV includes the negative outcomes, risks and complications of representative, specific surgical procedures.

I. Adverse Events, Risks, and Complications of Any Surgical Type

This section covers adverse events, risks, and complications associated with all operative procedures in general and are NOT specific to the surgical method or approach used(for example, abdominal/laparotomy incision (“open surgery”), thoracotomy incision, thoracoscopy, da vinci system robotic-assisted laparoscopy, and conventional laparoscopy).

1. 1. Intraoperative

  • Bleeding, excessive >500 mL, requiring blood transfusion
  • Injury (inadvertently caused by laceration, tear, perforation, puncture, electrocautery) to organ , structure, or tissue , including , but not limited to: major blood vessel, hollow viscous organs (bowel, bladder), solid organs (spleen, kidney, liver, heart, lung), ureter, nerve
  • Loss of needle, instrument fragment or any foreign body during surgery in patient’s body
  • Anesthesia risks (including heart attack, stroke, deep venous thrombosis, pulmonary embolism, pneumonia, dental injury, vocal cord injury and death)
  • Patient positioning injury: hemodynamic, intraocular pressure, neurologic, soft tissue injuries

2. Postoperative

These complications may resolve on their own with non-operative therapy, may require medical/pharmaceutical treatment such as antibiotics, may require radiological intervention such as drain placement or embolization, may require prolonged hospitalization, may require re-admission to the hospital, or may require surgical intervention such as re-operation.

  • Bleeding
  • Urinary: urinary tract infection, urinary retention
  • Gastrointestinal: ileus, nausea/vomiting, small bowel obstruction
  • Cardiac: myocardial infarction, arrhythmia, pericarditis
  • Thromboembolic: deep venous thrombosis, pulmonary embolus
  • Pulmonary: atelectasis, pneumonia, pleural effusion, pulmonary edema, need for re-intubation or prolonged intubation
  • Infection / Hematoma / Fluid Collection / Abscess (intra-abdominal, intra-pelvic, intra- thoracic)
  • Peritonitis
  • Rhabdomyolysis
  • Injury to adjacent organs
  • Serous drainage from wound, prolonged or excessive
  • Wound infection: incisional
  • Fascial dehiscence: incisional
  • Hernia: incisional
  • Renal: acute renal failure
  • Neuropathy; persistent pain
  • Visual loss, temporary or permanent
  • Spread of cancer cells
  • Cerebrovascular: transient ischemic attack, ischemic or hemorrhagic stroke
  • Inability to work
  • Recurrence of disease or symptoms
  • Death

II. Adverse Events, Risks, and Complications of Minimally Invasive Surgery

This section covers adverse events, risks and complications associated specifically with operative procedures performed minimally invasively through an endoscopic approach in addition to the above listed risks (for example, conventional laparoscopy, transoral endoscopy and da vinci system robotic-assisted laparoscopy).

1. Intraoperative

  • Conversion to open or hand-assisted surgery (typically due to patient anatomy, severe inflammation or adhesions, intraoperative injury, technical malfunction, extent of malignant invasion, extent of disease, or inability of patient to tolerate pneumoperitoneum)
  • Veress needle or trocar injury to hollow viscous (bowel, bladder), solid organs (spleen, kidney, liver, heart, lung) or blood vessel
  • Veress needle or trocar injury to hollow viscous (bowel, bladder), solid organs (spleen, kidney, liver, heart, lung) or blood vessel
  • Neuropraxia related to patient positioning
  • Ocular or laryngeal-facial complications related to trendelenberg position
  • Ocular or laryngeal-facial complications related to trendelenberg position
  • Subcutaneous emphysema
  • Hemodynamic and physiologic changes from the pneumoperitoneum and gas used

2. After Surgery

  • Shoulder pain
  • Gas pain

III. Adverse Events, Risks and Complications of da vinci robotic –assisted surgery

In addition to the risks in I and II above, which are not unique to da vinci, this section covers negative outcomes, risks and complications of da vinci robotic-assisted surgery. Surgery facilitated by the da vinci Surgical System may be associated with longer operative and anesthesia times than surgery with other approaches. As with any surgical device, there is also the risk that the da vinci robotic surgical system could malfunction or fail leading to serious injury or the need to switch to another type of surgical approach. Switching to another surgical approach type could also result in a longer procedure time, a longer time under anesthesia and increased complications.

IV. Adverse Events, Risks and Complications of Representative Specific Procedures

This section covers adverse events, risks and complications associated with specific operative procedures, not specific to the surgical method or approach used (for example, abdominal/laparotomy incision, thoracotomy incision, da vinci system robotic-assisted laparoscopy, and conventional laparoscopy). These procedural risks are in addition to the risks described under Sections I, II and III above.

Note: Not all procedures listed below are available for all da Vinci systems, instruments and accessories

Urology

Radical Prostatectomy: surrounding nerve damage which can lead to urinary incontinence and/or erectile dysfunction, rectal or bowel injury, urethral stricture, lymphocele, lymphedema; bowel obstruction

Pyeloplasty: pyelonephritis, anastomotic leak, ureteral stricture, bowel injury, urinoma, stone formation, stent migration or obstruction, hematuria, prolonged urinary leak

Cystectomy: urine leak, rectal injury, anastomotic stricture, fistula formation, incontinence, impotence, pelvic lymphocele

Nephrectomy: renal insufficiency, urine leak, splenic, hepatic or pancreatic laceration, bowel injury, pneumothorax, diaphragmatic injury, urinary fistula, urinoma, renal infarction, lymphocele

Ureteral Reimplantation: pyelonephritis, urinary extravasation, anastomotic stricture, ureteral reflux

Gynecology

Hysterectomy, Benign: urinary tract injury, vaginal cuff problem (separation, adhesions, granulation tissue, infection, cellulitis, hematoma), bladder injury, bowel injury, vaginal tear or laceration, vaginal shortening, voiding dysfunction, fistula formation: vesicovaginal, rectovaginal. Uterine tissue may contain unsuspected cancer. The cutting or morcellation of uterine tissue during surgery may spread cancer, and decrease the long-term survival of patients.

Hysterectomy (Malignant): urinary tract injury, vaginal cuff problem (separation, adhesions, granulation tissue, infection, cellulitis, hematoma), bladder injury, bowel injury, vaginal tear or laceration, vaginal shortening, voiding dysfunction, fistula formation: vesicovaginal, rectovaginal.

Myomectomy: uterine perforation, uterine rupture, preterm birth, spontaneous abortion Uterine tissue may contain unsuspected cancer. The cutting or morcellation of uterine or fibroid tissue during surgery may spread cancer, and decrease the long-term survival of patients.

Sacrocolpopexy: mesh erosion/infection (if mesh used in repair) with need for re-operation, rectal injury, bladder injury, rectocele, cystocele, urinary tract injury, vaginal cuff dehiscence, urinary incontinence, hematoma (retropubic, perineal or other).

Endometriosis resection: bowel injury, bladder injury, urinary tract injury

General Surgery

Cholecystectomy: common bile duct injury; bile leak; pancreatitis, retained common bile duct stones

Nissen Fundoplication: gastric, duodenal or esophageal perforation, herniation of wrap, slipped wrap, dysphagia, pneumothorax, peri-esophageal abscess, esophageal stricture, hiatal hernia, gas bloat syndrome, splenic injury

Paraesophageal and Other Hiatal Hernia Repairs: gastric, duodenal or esophageal perforation, herniation of wrap, dysphagia, pneumothorax, esophageal stricture, hiatal hernia, gas bloat syndrome, delayed gastric emptying,
heartburn, reflux

Heller Myotomy: gastric, duodenal or esophageal perforation, herniation of wrap, dysphagia, pneumothorax, esophageal stricture, hiatal hernia, heartburn, reflux

Bariatric Procedures (Sleeve Gastrectomy/ Roux-en-y gastric bypass, Duodenal Switch):anastomotic/staple line leak, malnutrition, anastomotic stricture, dumping syndrome, dehydration, dysphagia

Donor Nephrectomy: renal insufficiency, splenic, pancreatic or hepatic laceration, adrenal hematoma, pancreatitis, pneumothorax, diaphragmatic injury

Gastrectomy:anastomotic or duodenal leak, anastomotic stricture, dysphagia, pneumothorax

Pancreatic Procedures (Pancreatectomy and Whipple Procedure): pancreatitis, pancreatic leak, biliary leak, anastomotic leak, anastomotic stricture, splenic injury, pancreatic insufficiency, intestinal injury, delayed gastric emptying, diarrhea

Adrenalectomy: splenic injury, pancreatitis, diaphragmatic injury, adrenal hematoma

Splenectomy: pancreatic injury, kidney injury, adrenal injury, pancreatitis, pancreatic leak, portal vein thrombosis

Hernia Repair (ventral, incisional, umbilical, inguinal): recurrence, bowel injury, mesh infection, urinary retention. For inguinal hernia repair: testicular injury

Bowel Resection and Other Colorectal Procedures (Colectomy, Sigmoidectomy, Low Anterior Resection, APR, Intersphincteric Resection, Proctectomy, Rectopexy): anastomotic leak, anastomotic stricture, colorectal or anorectal dysfunction

Cardiac Surgery

Internal Mammary Artery Mobilization: graft injury, graft stenosis, cardiac arrest, embolism, low cardiac output syndrome, persistent coagulopathy, post-pericardiotomy syndrome, structural damage, arrhythmia, heart block, prolonged ventilation >48 hours, sternal de-vascularization

Cardiac Tissue Ablation: thromboembolism, circumflex artery injury, cardiac perforation, esophageal injury

Mitral Valve Repair: failed repair requiring replacement or repair, embolic stroke, ischemic heart failure, aortic dissection, prolonged ventilation >48 hours, prolonged time for: a heart-lung bypass, extracorporeal membrane oxygenation, intraaortic balloon pump or other cardiac assist systems, pulmonary edema, acute limb ischemia, valve infection, arrhythmia requiring pacemaker implantation, post-pericardiotomy syndrome (low grade fever and chest pain up to 6 months), pericarditis, persistent coagulopathy, heart attack, pericardial tamponade, memory loss and/or loss of mental clarity, arterial dissection, circumflex coronary artery injury, inadequate closure

Endoscopic Atrial Septal Defect Closure: failed closure of defect, embolic stroke, ischemic heart failure, aortic dissection, prolonged ventilation >48 hours, prolonged time for: a heart-lung bypass, extracorporeal membrane oxygenation, intraaortic balloon pump or other cardiac assist systems, pulmonary edema, acute limb ischemia, arrhythmia, heart block, cardiac arrest, hemothorax, pericardial tamponade, valve dysfunction, thromboembolism, thrombus formation, aortic dissection, arterial dissection, acute respiratory distress syndrome (ARDS), post-pericardiotomy syndrome, pericarditis, heart failure, persistent coagulopathy

Mammary to Left Anterior Descending Coronary Artery Anastomosis for Cardiac Revascularization with Adjunctive Mediastinotomy: graft injury, graft stenosis, failed anastomosis, cardiac arrest, embolic stroke, aortic dissection, acute limb ischemia, heart attack, arrhythmias, prolonged ventilation >48 hours, prolonged time for: a heart-lung bypass, extracorporeal membrane oxygenation, intraaortic balloon pump or other cardiac assist systems, valve dysfunction, hemothorax, pericardial tamponade, persistent coagulopathy, post-pericardiotomy syndrome, memory loss and/or loss of mental clarity, kidney or lung failure, heart failure

Pediatric Surgery

The Intuitive Surgical Endoscopic Instrument Control System has been successfully used in the pediatric surgical procedures listed below, among others.The Intuitive Surgical Endoscopic Instrument Control System has been successfully used in the pediatric surgical procedures listed below, among others..

Pyeloplasty: pyelonephritis, anastomotic leak, ureteral stricture, bowel injury, urinoma, stone formation, stent migration or obstruction, hematuria, prolonged urinary leak

Ureteral reimplantation: pyelonephritis, urinary extravasation, anastomotic stricture, voiding dysfunction,

Cholecystectomy: common bile duct injury; bile leak; pancreatitis, retained common bile duct stones

Nissen Fundoplication: gastric, duodenal or esophageal perforation, herniation of wrap, slipped wrap, dysphagia, pneumothorax, peri-esophageal abscess, esophageal stricture, hiatal hernia, gas bloat syndrome, splenic injury

Aortic Ring Ligation: respiratory failure

Patent Ductus Arteriosus Ligation: cardiorespiratory instability, ductal pseudoaneurysm, vocal cord dysfunction, pneumothorax, chylothorax, pulmonary arterial dilatation

Atrial Septal Defect Closure:structural deterioration of repair, arrhythmia, heart block, cardiac arrest, prolonged ventilation >48 hours, prolonged time for: a heart-lung bypass, extracorporeal membrane oxygenation, intraaortic balloon pump or other cardiac assist systems, hemothorax, pericardial tamponade, valve dysfunction, thromboembolism, thrombus formation, aortic dissection, acute limb ischemia arterial dissection, acute respiratory distress syndrome (ARDS), post-pericardiotomy syndrome, pericarditis, heart failure, persistent coagulopathy

Thoracic Surgery

Pulmonary Resection (Wedge Resection, Segmentectomy, Lobectomy): persistent air leak, pneumonia, prolonged mechanical ventilation >48 hours, atrial fibrillation, acute respiratory distress syndrome (ARDS), chylothorax, re-intubation, arrhythmias, bronchopleural fistula, phrenic nerve injury, esophageal injury, difficulty breathing, collapsed lung, pulmonary volvulus, recurrent laryngeal nerve injury leading to vocal cord dysfunction

Esophagectomy: anastomotic leak, pneumonia, cardiac complications (infarction, failure, atrial fibrillation), recurrent laryngeal nerve injury, chyle leak.

Mediastinal Mass Resection: prolonged ventilation >48 hours, persistent air leak, pericardial effusion, mixed respiratory syndrome, chylothorax, pneumothorax, re-intubation, pneumonia, difficulty breathing, acute respiratory distress syndrome (ARDS), atrial fibrillation, cardiac injury, conversion to sternotomy, recurrent laryngeal nerve injury leading to vocal cord dysfunction, phrenic nerve injury

Thyroidectomy: transient or permanent hypoparathyroidism/hypocalcemia, recurrent laryngeal nerve injury, re-intubation, tracheal laceration, vocal cord dysfunction, cosmetic deformity, persistent pain or numbness, transection of carotid sheath structures. NOTE: Thyroidectomy is considered an off-label procedure in the US.

NOTE: Thyroidectomy is considered an off-label procedure in the US.

Transoral Robotic Surgery (TORS): transoral bleeding which could include life threatening bleeds, difficulty swallowing which could include need for a permanent feeding tube with no eating by mouth, airway obstruction, re-intubation, need for tracheotomy, tracheostomy placement, prolonged intubation and need for ventilation, paralysis of tongue, difficulty opening mouth or trismus, broken teeth, pharyngeal stenosis, laryngeal stenosis, changes in speech or voice quality, salivary gland fistula, vocal cord damage, speech and swallowing dysfunction, dysphagia, dysphonia, lingual hypoesthesia, lip injury: abrasion, laceration, thermal trauma, dysguesia, hypoglossal nerve injury and tongue-weakness changes in taste sensitivity with loss of sense of taste. NOTE: Transoral Robotic otolaryngology surgical procedures are restricted to benign and malignant tumors classified as T1 and T2 and for benign base of tongue resection procedures.

©2015 Intuitive Surgical, Inc. All rights reserved. Product names are trademarks or registered trademarks of their respective holders.

PN 1009326 Rev F 11/2015


Labeling Information for Surgeons

Surgical Risks

Surgeons should counsel their patients that serious complications may occur with any surgery, including da Vinci Surgery, up to and including death. Examples of serious and life-threatening complications, which may require prolonged and/or unexpected hospitalization and/or reoperation, include but are not limited to, one or more of the following:

  • Injury to tissues and/or organs
  • Bleeding
  • Infection
  • Internal scarring that can cause long-lasting dysfunction or pain.

Surgeons should discuss these and all risks associated with surgery with their patients, including but not limited to the following:

  • Potential for human error
  • Potential for equipment failure
  • Potential for anesthesia complications

Individual surgical results may vary.

Risk specific to minimally invasive surgery, including da Vinci® Surgery, include but are not limited to:

  • Temporary pain or nerve injury associated with positioning;
  • A longer operative time;
  • The need to convert the procedure to an open approach;
  • Converting the procedure could mean a longer operative time, a longer time under anesthesia, and/or the need for additional or larger incisions and/or increased complications.

Surgeons should counsel their patients that there are other surgical approaches available. You should discuss your surgical experience and review these and all risks with your patients. Patients and physicians should  review all available information on non-surgical and surgical options in order to make an informed decision. Clinical studies are available through the National Library of Medicine at www.ncbi.nlm.nih.gov/pubmed.

Be sure to read and understand all information in the applicable user manuals, including full cautions and warnings, before using da Vinci products. Failure to properly follow all instructions may lead to injury and result in improper functioning of the device. Training provided by Intuitive Surgical is limited to the use of its products and does not replace the necessary medical training and experience required to perform surgery. Procedure descriptions are developed with, reviewed and approved by independent surgeons. Other surgical techniques may be documented in publications available at the National Library of Medicine. For Important Safety Information, indications for use, risks, full cautions and warnings, please also refer to www.davincisurgery.com/safety and www.intuitivesurgical.com/safety. Unless otherwise noted, products featured are available for commercial distribution in the U.S. For availability outside the U.S., please check with your local representative or distributor.

Appropriate Use of the da Vinci System
There are several models of the da Vinci System. Below are the cleared indications for use in the U.S. for the various models. Important Safety Information, Instructions for Use, Contraindications, Warnings, and Precautions are included in the product instructions provided with the system, instruments and accessories. Contraindications applicable to the use of conventional endoscopic instruments also apply to the use of all da Vinci instruments.

Note: Include only the applicable da Vinci System description(s) below in your all-Inclusive disclosure statement. Use one or both as appropriate. This is very important for regulatory compliance.

da Vinci S, Si-e and Si System Models
The Intuitive Surgical Endoscopic Instrument Control Systems (da Vinci, da Vinci S and da Vinci Si Surgical Systems Models IS1200, IS2000, IS3000) are intended to assist in the accurate control of Intuitive Surgical EndoWrist Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic/harmonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, transoral otolaryngology surgical procedures restricted to benign and malignant tumors classified as T1 and T2, and for benign base of tongue resection procedures, general thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system can be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use except for transoral otolaryngology surgical procedures. It is intended for use by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use. The safety and effectiveness of this device for use in the treatment of obstructive sleep apnea have not been established.

da Vinci Xi System Model
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical Systems Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically assisted cardiotomy procedures. The system can be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use. It is intended for use by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use. 

Product Availability
Unless otherwise noted, products featured are available for commercial distribution in the U.S. Some products may not be available worldwide and may not be used for all applications. For availability outside the US, please check with your local representative or distributor.

Intuitive-Provided Instruction
Training provided by Intuitive Surgical is limited to the use of the da Vinci Surgical System and does not replace the necessary medical training and experience required to perform surgery. The da Vinci Surgical System should be used only by surgeons who have received specific training in its use.

Intuitive Surgical facilitates peer-to-peer clinical teaching. Intuitive Surgical does not teach surgery, nor does it provide or evaluate surgical credentialing. Procedure descriptions are developed with, reviewed and approved by independent surgeons.

Intuitive Surgical-sponsored presentations, instruction and promotional materials are intended for general information only and are not intended to substitute for formal medical training or certification. da Vinci® Surgical System training programs are not replacements for hospital policy regarding surgical credentialing. Certification, OR access and hospital privileges are the responsibility of the surgeon and their institutions, not that of Intuitive Surgical.

Any demonstration during Intuitive Surgical-sponsored training or instructional material on how to use the system to perform a particular technique or procedure is not the recommendation or "certification" of Intuitive Surgical as to such technique or procedure, but rather is merely a sharing of information on how other surgeons may have used the system to perform a given technique or procedure. Clinical information and opinions expressed by training participants, including any inaccuracies or mistakes, belong to the individual. Information and opinions are not necessarily those of Intuitive Surgical, Inc.

User Responsibilities
Before performing any da Vinci® procedure, physicians are responsible for receiving sufficient training and proctoring to ensure that they have the skill and experience necessary to protect the health and safety of their patients.

Users of the da Vinci System must follow all instructions for use supplied with the system, instruments and accessories. Use of da Vinci instruments for tasks other than that for which they were designed may result in damage or breakage. Unless stated in the instructions, do not use EndoWrist instruments on cartilage, bone or hard objects. Failure to follow instructions may lead to serious injury or surgical complications for the patient, including death. Electrosurgical energy may cause burns, serious injury or complications to the patient, including death. It is important to fully understand the da Vinci System energy user interface, not exceed recommended energy levels and to use caution when working near critical anatomy.

For Important Safety Information, including indications for use and full cautions and warnings, please also refer to the product instructions for use. Read all instructions carefully. Failure to properly follow instructions, notes, cautions, warnings and danger messages associated with this equipment may lead to serious injury or complications for the patient, including death.

In the event that the da Vinci System, instruments, or accessories do not work as expected or if you are aware of a product deficiency or adverse event, please contact Intuitive Surgical Customer Service immediately. Please refer to the Customer Service contact information in the product Instructions for Use.

Intuitive Surgical promotes and facilitates the use of the da Vinci System for commercial use only in conjunction with on-label  procedures set forth in the Instructions for Use. Intuitive Surgical recommends consulting your institutional policy regarding the use of cleared medical devices for off-label procedures prior to utilizing the da Vinci System.

PN 1006733 Rev C 07/2015