Reported Jun 8, 2022 · Completed
DAVINCI | Energy SynchroSeal da Vinci X' da Vinci Xi', Single Use Instrument 8mm, REF 480440
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 101 · Sunnyvale, CA · 94086-5304
Is this the product you have?
- DAVINCI | Energy SynchroSeal da Vinci X' da Vinci Xi', Single Use Instrument 8mm, REF 480440
- Lot codes and dates
- UDI00886874117309. All lots
- Amount recalled
- 7,995 boxes (or 47,972 individual units ; 6 instruments/box)* The total amount will continue to grow until updated user documentation is distributed
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
Placing excessive tissue in the instrument jaws of the devices prior to sealing and transection can result in an insufficient seal.
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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