Reported Jun 12, 2013 · Terminated
8 mm Monopolar Curved Scissors (a.k.a. Hot Shears) Manufactured and Distributed by: Intuitive Surgical Sunny vale, CA…
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?
- 8 mm Monopolar Curved Scissors (a.k.a. Hot
- Shears) Manufactured and Distributed byIntuitive Surgical Sunny vale, CA The EndoWrist Monopolar Curved Scissors Instrument is a multiple-use endoscopic instrument utilizing a single use, tip cover accessory, to be used in conjunction with the Intuitive Surgical Endoscopic Instrument Control System
- Lot codes and dates
- Model Numbers 420179-09 and -10 and 400179-09 and -10.
- Amount recalled
- ~132,441 instruments
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
Intuitive Surgical has identified a potential for some units of the Monopolar curved Scissors version 09 and 10 instruments to develop very small cracks near the distal end. This may create a pathway for electrosurgical energy to leak to tissue and potentially cause thermal injury.
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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