Device product
Microline Renew Fenestrated Control Tip Grasper, Single Patient Use, Product Number: 3222 The ReNew Fenestrated Grasper Forceps Tips are intended to cut, grasp, and dissect various abdominal tissue for use in endoscopic, including laproscopic surgical procedures where instruments are introduced onto the body through a cannula.
Z-1635-2014
Product summary
- Event
- Event 68012
- Status
- Terminated
- Classification
- Class II
- Quantity
- 540 units
- Official record key
device-enforcement:Z-1635-2014
Official wording
Reason: Grasper jaw may break when force is applied to the jaw
Code information: Lot Numbers: 00116169 and 00115866
Distribution pattern: Worldwide Distribution - US including the states of TX, IL, TN and NY, and the country of Chile.
Derived failure modes
-
Unknown
Grasper jaw may break when force is applied to the jaw