Recall Z-1568-2016 ยท NAY System, Surgical, Computer Controlled Instrument
Intuitive Surgical, Inc.
EndoWrist Stapler 45 and Stapler 30 instruments used on the da Vinci Xi systems (IS4000) with p5 software. General Surgery: The Intuitive Surgical Endoscope 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, scalp
| Date | Mar 25, 2016 |
| Status | Terminated |
| Reason | Potential for unexpected motion of the Xi Stapler jaws on the da Vinci Xi System with p5 software relating to a combination of the p5 software and the surgeon quickly transitioning from the clamp to the fire pedal during use. |
| Root cause | Software design |
| Action | Intuitive Surgical sent an Urgent Product Safety notification to customers via e-mail on March 25, 2016. Customers were advised to STOP USE on the EndoWrist Stapler 45 and 30 instruments on da Vinci XI systems with p5 software. Product letters followed and were mailed on March 31, 2016 by Fed Ex. Urgent Medical Device letters were sent via Fed Ex on March 31, 2016 (dated April 1, 2016). These letters reiterated what was explained in the previous e-mail and provide more information of the unexpected motion issue. In addition to the stop use request, letters requested that all personnel be fu |
| Quantity | 43 |
| Distribution | US Nationwide Distribution in the states of: WI, FL, OH, TX, CA, AZ, IL, MD, MN, NY, OK, HI, MO, IA, KS, PA, and AL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131861 | DA VINCI SURGICAL SYSTEM, ENDOWRIST INSTRUMENTS AND ACCESSORIES Intuitive Surgical, Inc., Mar 28, 2014 |