Intuitive Surgical Recalls 8MM Micro Bipolar Forceps for Frayed or Broken Grip Cables
Intuitive Surgical recalls 1,036 units of 8MM Micro Bipolar Forceps due to increased complaints of frayed or broken grip cables that could affect instrument function 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 FDA Class II recall addresses grip cable failure on surgical forceps. The hazard represents a risk-of-harm product where instrument malfunction during surgery could lead to serious complications, but no reported injuries or illnesses have been documented, keeping the score at 3 per the rubric.
Plain-English summary
Intuitive Surgical, Inc. has recalled 1,036 units of 8MM Micro Bipolar Forceps (Model 471171) due to increased complaints of frayed or broken grip cables on the reusable instruments.
The recalled instruments have the part number 471171-15 and UDI-DI code 00886874121474. They were distributed nationwide throughout all U.S. states and territories, and internationally across more than 50 countries and territories.
The recalled batches are identified by the following batch numbers: K10230405, K10230413, K10230601, K10230615, K10230713, K10230817, K10230907, K10230913, K10231103, K10231123, K10231130, K10231207, K10231214, K10231221, K10240104, K10240118, K10240208, K10240222, K10240327, K10240411, K10240502, K10240516, K10240702, K10240711, K16240508, and K16240530.
The recalled product
- Product
- 8MM,MICRO BIPOLAR FORCEPS,IS4000 REF 471171
- Manufacturer
- Intuitive Surgical, Inc.
- Hazard
- broken-grip-cable
- frayed-grip-cable
Distribution
Distribution scope not specified by the agency.
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