Washington, DC: The Intuitive Surgical Endoscopic Instrument Control System (Intuitive Surgical da Vinci Surgical System Model IS2000/3000) is being recalled due to an alleged design defect. The class II recall was issued in December 2013, by Intuitive Surgical Inc in conjunction with the FDA.
The Intuitive Surgical da Vinci Surgical System Model IS2000/3000 is intended to assist in the accurate control of a variety of Intuitive Surgical Endoscopic Instruments in a wide range of surgical procedures in both adults and children.
Intuitive Surgical has received reports of friction within certain instrument arms that can interrupt smooth instrument motion. This can be felt by the surgeon as resistance in the movement of the master. In this situation, the instrument can stall momentarily and then suddenly catch-up to the master position if the surgeon pushes through the resistance. The FDA has determined this is the result of defective device design.