Reported Dec 25, 2013 · Terminated
Mega Needle Driver, 8MM assembly of the da Vinci S IS1200 and da Vinci Si, IS2000. Manufactured by Intuitive Surgical,…
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?
- Mega Needle Driver, 8MM assembly of the da Vinci S IS1200 and da Vinci Si, IS2000. Manufactured by Intuitive Surgical, Sunnyvale, CA. EndoWrist Instruments, including scissors, scalpels, forceps, needle drivers and electrocautery are intended for endoscopic manipulation of tissue
- includinggrasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery and suturing. Mega Needle Driver and Large Needle Driver instruments are part of the EndoWrist instrument family and are intended for use in endoscopic manipulation and suturing
- Lot codes and dates
- Part number 400194 on da Vinci IS1200
- Lot numbers
72 of 72 codes
710191M10110114710197M10110204710261M10110217711061M10110307711121M10110321711191M10110425712071M10110523712171M10110603801041M10110621801151M10110725801171M10110728801301M10110810803171M10110816804121M10110831805091M10110909805271M10110920M10090320S10080609M10090512S10080621M10090709S10080729M10090731S10080812M10090812S10080822M10090824S10080910M10090909S10080918M10091020S10081010M10091110S10081029M10091130S10081106M10091211S10081114M10100114S10081201M10100216S10081215M10100218S10090106
- Part number 420194 - used on IS2000lot
- numbers
188 of 188 codes
510071M10090629S10080802710191M10090706S10080818710261M10090724S10080822711061M10090727S10080902711121M10090731S10080910711151M10090810S10080917711191M10090825S10080926712051M10090828S10080930712131M10090909S10081002712262M10090916S10081009801021M10091005S10081014801151M10091008S10081016801181M10091012S10081029801241M10091030S10081106801301M10091105S10081114802121M10091123S10081119802201M10091124S10081202802251M10091130S10081209803121M10091204S10081218803211M10091211S10081229
- Amount recalled
- 15, 236 UPDATED 12/19/13 to 11,235
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
Firm has become aware of the potential for detachment of the jaw insert for Large Needle Drivers and Mega Needle Drivers.
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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