Tenaculum Forceps for da Vinci Surgical Systems Recalled Due to Pitch Cable Failures
Intuitive Surgical is recalling 8MM Tenaculum Forceps used with da Vinci X/Xi Surgical Systems due to pitch cable failures. These instruments are used for tissue manipulation and retraction during surgical procedures.
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: Class II device recall due to pitch cable failures in surgical instruments. No injuries or hospitalizations are reported in the source material, fitting the 'risk-of-harm product without reported injury' category per the rubric.
Plain-English summary
The 8MM Tenaculum Forceps (Product Number 470207) manufactured by Intuitive Surgical, Inc. is being recalled. This surgical instrument is used with da Vinci X/Xi Surgical Systems to perform procedures including tissue manipulation and retraction. Approximately 33,219 units have been distributed.
The recall is due to an increase in complaints involving pitch cable failures. These failures could impair the instrument's function during surgery, potentially affecting patient care.
The affected instruments have been distributed nationwide throughout the United States and internationally to healthcare facilities in Canada, Europe, Asia, and other regions. Specific lot numbers associated with the recall are available from the FDA.
Healthcare providers should stop using affected instruments and contact Intuitive Surgical, Inc. for information regarding replacement, repair, or return of the recalled devices.
The recalled product
- Product
- 8MM, Tenaculum Forceps REF 470207 Instrument used with the da Vinci X/Xi Surgical Systems in a wide variety of procedures to perform a variety of surgical tasks including manipulation and retraction of tissue.
- Manufacturer
- Intuitive Surgical, Inc.
- Hazard
- cable-failure
- equipment-malfunction
Distribution
Distributed nationwide across the United States.
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