Intuitive Surgical Bipolar Dissectors Recalled for Frayed Grip Cables
Intuitive Surgical is recalling 141 curved bipolar dissectors due to complaints of frayed or broken grip cables on the reusable surgical instruments.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall involving mechanical failure of a reusable surgical instrument. Although no injuries or illnesses have been reported, frayed or broken grip cables on a surgical instrument present a potential risk-of-harm, meeting the criteria for a High severity rating.
Plain-English summary
Intuitive Surgical, Inc. is recalling 141 units of the 8MM Curved Bipolar Dissector, Model IS4000 (Reference 470344), a reusable surgical instrument. The recall was initiated due to increased complaints regarding frayed or broken grip cables on these instruments with jaws.
The affected units were distributed nationwide across all U.S. states and territories, as well as internationally to more than 40 countries.
The recalled product
- Product
- 8MM,CURVED BIPOLAR DISSECTOR,IS4000¿ REF 470344
- Manufacturer
- Intuitive Surgical, Inc.
- Hazard
- cable-failure
Distribution
Distribution scope not specified by the agency.
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