Reported Sep 19, 2012 · Terminated
Tip Cover for 8mm Monopolar Curved Scissors (Hot Shears)Accessory, Disposable, 8mm MCS, Box of 10. The intended use of…
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?
- Tip Cover for 8mm Monopolar Curved Scissors (Hot Shears)Accessory, Disposable, 8mm MCS, Box of 10. The intended use of the Tip Cover Accessory is to provide dielectric insulation over a section of the Monopolar Curved Scissor instrument so that RF energy is only available at the scissor blades. The Monopolar Curved Scissors are intended for endoscopic manipulation of tissue
- includingcutting, blunt and sharp dissection, electrocautery. This accessory is to be used with the Intuitive Surgical Endoscopic Instrument Control Systems (da Vinci, da Vinci S and da Vinci Si Surgical Systems Models IS1200, 12000, ISSOQO)
- Lot codes and dates
- Model No. 400180-12
- Lot No
M10120601M10120430M10120329M10120312M10111214M10120516M10120426M10120321M10120208M10111208M10120510M10120419M10120317M10120207M10111201M10120507M10120413M10120315M10120130M10111028
- Amount recalled
- 11,121 Boxes
Where it was sold
- Nationwide
- PR
Why it was recalled
There is potential for the sterility of the product to be compromised.
This product could cause temporary or reversible health problems — stop using it.
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