Device product
Codman ISOCOOL Bipolar Forceps-are indicated for cauterizing, coagulating, grasping, and manipulating tissue during general surgery, neurosurgery, ENT surgery, OB/GYN surgery, and maxillofacial / plastic surgery procedures. Model # 8145100S
Z-2206-2019
Product summary
- Event
- Event 83485
- Status
- Terminated
- Classification
- Class II
- Quantity
- 125 units
- Official record key
device-enforcement:Z-2206-2019
Official wording
Reason: Tips have an inadequate product insulation coating, which could result in the tips not coagulating as expected
Code information: Lot # J2670Y
Distribution pattern: KY,NJ, RI, TX, WA Foreign: BE
Derived failure modes
-
Unknown
Tips have an inadequate product insulation coating, which could result in the tips not coagulating as expected