Reported May 4, 2016 · Terminated
EndoWrist Stapler 45 and Stapler 30 instruments used on the da Vinci Xi systems (IS4000) with p5 software. General…
Intuitive Surgical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Intuitive Surgical, Inc. · 1266 Kifer Rd Bldg 100 · Sunnyvale, CA · 94086-5304
Is this the product you have?
- EndoWrist Stapler 45 and Stapler 30 instruments used on the da Vinci Xi systems (IS4000) with p5 software
- General SurgeryThe 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, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximations, ligation, electrocautery, suturing and delivery and placement of microware 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
- Lot codes and dates
- da Vinci systems with serial numbers
SK0036SK0292SK0650SK0039SK0293SK0652SK0057SK0294SK0653SK0101SK0326SK0654SK0106SK0358SK0665SK0119SK0360SK0701SK0143SK0382SK0702SK0144SK0408SK0710SK0146SK0438SK0722SK0171SK0456SK0728SK0173SK0484SK0181SK0492SK0216SK0496SK0230SK0516SK0233SK0548SK0237SK0552SK0238SK0610SK0263SK0612SK0286SK0631SK0291SK0649
- da Vinci systems with serial numbers
- Amount recalled
- 43
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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