8MM Maryland Bipolar Forceps Recalled Due to Frayed Grip Cables
Intuitive Surgical is recalling 8MM Maryland Bipolar Forceps due to increased complaints about frayed or broken grip cables on these reusable surgical instruments. Approximately 7,132 units have been distributed.
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: FDA Class II recall of surgical instruments with grip cable defects. No injuries reported. The defects present a risk of harm during surgical procedures, meeting the Score 3 criterion for risk-of-harm products without reported injury.
Plain-English summary
Intuitive Surgical, Inc. is recalling the 8MM Maryland Bipolar Forceps (Model 470172), a reusable surgical instrument. The device is used in operating rooms for surgical procedures. Approximately 7,132 units have been distributed throughout the United States and to 49 additional countries.
The recall is due to increased complaints regarding frayed or broken grip cables on the affected instruments.
Healthcare facilities and surgical centers that have received these devices should discontinue use of affected instrument lots. Contact Intuitive Surgical for instructions on device inspection, repair, replacement, or return.
The recalled product
- Product
- 8MM,MARYLAND BIPOLAR FORCEPS,IS4000 ¿ REF 470172
- Manufacturer
- Intuitive Surgical, Inc.
- Hazard
- grip-cable-failure
- mechanical-defect
Distribution
Distribution scope not specified by the agency.
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