Company

Indications for Use, United States

The Indications for Use statements below are for customers within the United States. Customers outside of the US can visit the Intended Use page or contact their local distributor or nearest Intuitive Surgical office for additional information.

da Vinci Xi® Surgical System

The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, 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, ultrasonic shears, 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 also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use. It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.

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 S®, Si-e® and Si® – TransOral Robotic Surgery (TORS)

The da Vinci S, Si-e, and Si Systems are indicated for transoral otolaryngologic surgical procedures restricted to benign and malignant tumors classified as T1 and T2 and for benign base of tongue resection procedures. The safety and effectiveness of this device for use in the treatment of obstructive sleep apnea have not been established. These da Vinci® Systems are not indicated for pediatric transoral otolaryngology surgical procedures. The performance characteristics of the da Vinci Surgical Systems have not been established in patients with: poor mouth openings (< 1.5 cm), advanced tumors (e.g., invading the mandible, abutting the carotid artery, requiring bone resection, etc.), dental surgery (i.e. tooth extraction).

da Vinci® SP™ Surgical System

da Vinci® SP™ Surgical System, Model SP999
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci® SP™ Surgical System, Model SP999) is intended to assist in the accurate control of Intuitive Surgical EndoWrist® Sp™ Instruments during urologic surgical procedures that are appropriate for a single port approach. The system is indicated for adult 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.

EndoWrist® Sp™ Instruments
Intuitive Surgical EndoWrist® Sp™ Instruments are controlled by the da Vinci® SP™ Surgical System, Model SP999, and include flexible endoscopes, blunt and sharp endoscopic dissectors, scissors, 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, and suturing through a single incision laparoscopic approach. The system is indicated for urologic surgical procedures that are appropriate for a single port approach. The system is indicated for adult 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.

The safety and effectiveness of this device for use in the performance of general laparoscopic surgery procedures have not been established. This device is only intended to be used for single port urological procedures with the da Vinci EndoWrist Sp Instruments and the da Vinci Sp Surgical System (SP999).

da Vinci® Single-Site®

The Intuitive Surgical® da Vinci® Single-Site® Instruments and Accessories used with the da Vinci® Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation, electrocautery and suturing during single incision laparoscopic cholecystectomy, benign hysterectomy and salpingo-oophorectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, needle drivers, scissors, suction irrigators, monopolar cautery, bipolar cautery, 5 mm curved cannulae, 5 mm and 10 mm straight cannulae, flexible blunt obturators, and the Single-Site Port.

The safety and effectiveness of this device for use in the performance of general laparoscopic abdominal surgery or general gynecologic surgery procedures have not been established. This device is only intended to be used for single incision laparoscopic cholecystectomy, benign hysterectomy, and salpingo-oophorectomy with the da Vinci Single-Site Instruments and the da Vinci Si Surgical System (IS3000).

Firefly®

The da Vinci® Fluorescence Imaging Vision System (Firefly® Fluorescence Imaging) is intended to provide real-time endoscopic visible and near-infrared fluorescence imaging. The da Vinci Fluorescence Imaging Vision System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow, and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct), using near infrared imaging.

Fluorescence imaging of biliary ducts with the da Vinci Fluorescence Imaging Vision System is intended for adjunctive use only in conjunction with standard of care white light and, when indicated, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization

Other Instruments

For specific instrument indications for use, please refer to the instrument user documentation.

Serious complications may occur in any surgery, including da Vinci® Surgery, up to and including death. Individual surgical results may vary. Patients should talk to their doctor to decide if da Vinci Surgery is right for them. Patients and doctors should review all available information on non-surgical and surgical options in order to make an informed decision. Please also refer to http://www.daVinciSurgery.com/Safety for Important Safety Information.