Reported Oct 22, 2014 · Terminated
EndoWrist One Vessel Sealer used in conjunction with the da Vinci Si Surgical System IS3000. The Endo Wrist One Vessel…
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 One Vessel Sealer used in conjunction with the da Vinci Si Surgical System IS3000. The Endo Wrist One Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Si Surgical System and the ERBE VIO 300 D electrosurgical generator. It is intended for grasping and blunt dissection of tissue and for bipolar coagulation and mechanical transection of vessels up to 7 mm in diameter and tissue bundles that fit in the jaws of the instrument.
- Lot codes and dates
- Part Number
PN 410322-04-05
- Serial Numbers
780 of 780 codes
SH1484SH1879SH1875SH1485USG332SH0561USG803SH1406SH1405SH0034SH0554SH0554USG160USG575SH0908SH2066SH1455SH0975SH1475SH1168SH1552SH0608SH0608SH1756SH1716USG071USG038SH0607SH1590SH1686SH1639SH1688SH1740SH1932USG323SH1944USG286SH1945SH2022SH2085SH1108SH2047USG257USG435USG183SH2079USG035USG144USG647SH1590USG641SH0087USG580SH0389USG106SH1642USG351SH0280SH1963SH0566
- Part Number
- Amount recalled
- 1,483 devices
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Intuitive Surgical is initiating a voluntary correction relating to the labeling and software associated with the EndoWrist. One Vessel Sealer for the da Vinci Si (IS3000) Surgical System.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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