Reported Mar 4, 2015 · Terminated
EndoWrist One Vessel Sealer, IS3000, 6 pack used in conjunction with the da Vinci Surgical System Si IS3000 The…
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, IS3000, 6 pack used in conjunction with the da Vinci Surgical System Si IS3000 The EndoWrist One Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Surgical System and the ERBE VIO 300 D electrosurgical generator. It is intended for bipolar coagulation and mechanical transection of vessels up to 7mm in diameter and tissue bundles that fit the jaws of the instrument. PN 410322-05
- Lot codes and dates
- PN 410322-05Serial numbers
M10140807M10140926M10141028M10141119M11140917M11141119M10140812M10141001M10141029M10141125M11140922M11141125M10140814M10141004M10141031M10141126M11140926M11141126M10140818M10141006M10141104M10141128M11141001M11141201M10140826M10141009M10141105M10141201M11141004M10140828M10141015M10141107M11140808M11141006M10140902M10141020M10141111M11140818M11141009M10140905M10141022M10141113M11140826M11141015M10140917M10141023M10141114M11140828M11141020M10140922M10141024M10141117M11140904M11141024
- PN 410322-05Serial numbers
- Amount recalled
- 3282 total units, all part numbers
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
- PR
Why it was recalled
Intuitive Surgical has identified the potential for a certain, small portion of Vessel Sealers to exhibit interference in the back of the instrument grips due to manufacturing variability in some jaws.
This product could cause temporary or reversible health problems — stop using it.
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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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