Intuitive Surgical Bipolar Dissector Recalled for Frayed Grip Cables
Intuitive Surgical is recalling 8MM curved bipolar dissectors due to frayed or broken grip cables that could affect surgical instrument performance. Approximately 3,869 units were distributed nationwide and internationally.
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 FDA Class II recall involves a risk-of-harm medical device where mechanical failure of grip cables could affect proper instrument function during surgery. Although no reported illnesses or injuries are documented in the source text, the potential for patient harm from surgical instrument malfunction justifies a High severity rating.
Plain-English summary
Intuitive Surgical, Inc. is recalling its 8MM curved bipolar dissectors (Model 471344) due to reports of frayed or broken grip cables on the reusable surgical instruments. These grip cable failures could affect the proper function of the instrument during surgical procedures.
The recall affects approximately 3,869 units that were distributed nationwide throughout the United States as well as internationally to countries including Canada, Australia, Japan, and many others. The affected instruments are identified by model number 471344, part number 471344-17, and specific batch numbers produced between October 2023 and July 2024.
Healthcare facilities using these instruments should be aware of the potential grip cable failures. Affected instruments should not be used for surgical procedures until replacement or repair is obtained. Healthcare providers should contact Intuitive Surgical directly for replacement units or additional guidance.
The recalled product
- Product
- 8MM,CURVED BIPOLAR DISSECTOR,IS4000 REF 471344
- Manufacturer
- Intuitive Surgical, Inc.
- Hazard
- grip-cable-damage
- instrument-malfunction
Distribution
Distribution scope not specified by the agency.
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