Surgical Scissors Recalled for Frayed or Broken Grip Cables
Intuitive Surgical is recalling 8MM Potts Scissors due to frayed or broken grip cables that could affect instrument performance 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: This is an FDA Class II medical device recall for a surgical instrument with confirmed mechanical defects (frayed or broken grip cables). While no injuries or hospitalizations have been reported, surgical scissors are risk-of-harm devices where equipment failure could affect procedure safety.
Plain-English summary
Intuitive Surgical, Inc. is recalling the 8MM Potts Scissors (Model 470001) due to increased complaints regarding frayed or broken grip cables on the reusable instruments. The grip cables are a critical component that affects the functionality and safety of the scissors during surgical procedures.
Approximately 3,625 units have been distributed nationwide across the United States, Puerto Rico, and internationally. The affected batch numbers are K10230308, K11230308, and K10230517. Healthcare facilities and surgical centers that have received these instruments should stop using them immediately.
Patients and healthcare providers who have used or are currently using these scissors should contact their healthcare facility or Intuitive Surgical for instructions on device return and replacement. While no injuries have been reported to date, continued use of instruments with compromised grip cables could pose a risk during surgical procedures.
The recalled product
- Product
- 8MM, POTTS SCISSORS, IS4000 REF 470001
- Manufacturer
- Intuitive Surgical, Inc.
- Affected units
- 3,625
Distribution
Part of a larger recall action
This product is one of 37 recalled by Intuitive Surgical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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