Reusable Surgical Instruments Recalled for Frayed or Broken Grip Cables
Intuitive Surgical is recalling reusable surgical instruments due to reports of frayed or broken grip cables that may affect safe operation during 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: FDA Class II recall with no reported injuries or hospitalizations. The hazard involves grip cable failure in surgical instruments, which could affect functionality during use. Per the rubric, risk-of-harm products without reported injury score 3 (High).
Plain-English summary
Intuitive Surgical, Inc. is recalling specific models of reusable surgical instruments distributed nationwide and internationally. The recalled devices are 8MM MEGA SUTURECUT ND (Model 470309, Part Numbers 470309-15 and 470309-17) reusable cutting instruments with jaws used in surgical procedures.
The recall was initiated due to increased complaints of frayed or broken grip cables on these instruments. A grip cable failure could affect the instrument's functionality and safe operation during surgical use.
These instruments were distributed throughout the United States, Puerto Rico, and internationally to numerous countries. Healthcare facilities and surgical centers that have received these instruments should discontinue use immediately and contact Intuitive Surgical, Inc. for replacement or repair instructions. Affected devices carry batch numbers K10230217 and K10230302.
The recalled product
- Product
- 8MM,MEGA SUTURECUT ND,IS4000¿ REF 470309
- Manufacturer
- Intuitive Surgical, Inc.
- Hazard
- cable-breakage
- instrument-malfunction
Distribution
Distribution scope not specified by the agency.
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