November 19, 2013
Voluntary Product Correction for da Vinci® Patient Side Manipulators (PSMs)
Intuitive Surgical has issued a field notice informing affected da Vinci S, Si, and Si-e System customers that it is voluntarily initiating a correction for the Patient Side Manipulators (PSMs) on the Patient Side Cart and repairing or replacing them as needed. The PSM is commonly referred to as the instrument arm, which holds and drives the EndoWrist© instruments. This notice affects approximately 1,386 instrument arms worldwide, not da Vinci systems.
The company is taking this action after becoming aware that excessive friction within certain instrument arms could interrupt smooth instrument motion, which is felt as resistance by the surgeon. If a surgeon pushes through the resistance, the instrument could stall momentarily and then suddenly catch-up to the correct position.
Out of more than 55,000 procedures completed with this group of instrument arms, there has been one reported instance of interrupted motion resulting in an imprecise cut, along with two additional instances of perceived resistance. No patient complications were reported in association with these three instances. Intuitive Surgical is performing comprehensive inspections to test all affected instrument arms and repair or replace them as needed—nearly 70 percent of these inspections are complete and the large majority of inspected arms have not required adjustment.
The company has notified the appropriate regulatory authorities of this action.
About Intuitive Surgical, Inc.
Intuitive Surgical, Inc. (Nasdaq: ISRG), headquartered in Sunnyvale, Calif., is the global leader in robotic-assisted, minimally invasive surgery. Intuitive Surgical develops, manufactures and markets the da Vinci® Surgical System. Intuitive Surgical's mission is to extend the benefits of minimally invasive surgery to those patients who can and should benefit from it.
About the da Vinci Surgical System
The da Vinci Surgical System is a surgical platform designed to enable complex surgery using a minimally invasive approach. The da Vinci Surgical System consists of an ergonomic surgeon console or consoles, a patient-side cart with three or four interactive arms, a high-performance vision system and proprietary EndoWrist® instruments. Powered by state-of-the-art technology, the da Vinci Surgical System is designed to scale, filter and seamlessly translate the surgeon's hand movements into more precise movements of the EndoWrist instruments. The net result is an intuitive interface with improved surgical capabilities. By providing surgeons with superior visualization, enhanced dexterity, greater precision and ergonomic comfort, the da Vinci Surgical System makes it possible for skilled surgeons to perform more minimally invasive procedures involving complex dissection or reconstruction. For more information about clinical evidence related to da Vinci Surgery, please visit www.intuitivesurgical.com/company/clinical-evidence/.
PN 1004597 Rev A 09/2013