Reported Jun 5, 2013 · Terminated
Tip Cover Accessory, 8 MM, MCS, box of 10 Product Usage: The disposable Tip cover accessory is used in conjunction with…
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 Accessory, 8 MM, MCS
- box of 10 Product UsageThe disposable Tip cover accessory is used in conjunction with the 8mm Monopolar Curved Scissors Instruments to cut and coagulate tissue. The tip cover is intended to provide electrical insulation over a section of the Monopolar Curved Scissors instrument so that FR energy is only available at the scissors blades
- Lot codes and dates
- Model numbers
400180-10 and prior versions 400180-01400180-02400180-03400180-04400180-05400180-05400180-06. 400180-07400180-08 and 400180-09
- Model numbers
- Amount recalled
- 50,000 boxes of 10 tip covers
This recall covers 9 products
The agency filed one notice per product. You are reading one of them; the other 8 are below.
Where it was sold
- Nationwide
Why it was recalled
Clarification of existing labeling and related cautions for the tip cover accessory of the da Vinci Surgical System.
This product could cause temporary or reversible health problems — stop using it.
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