Device product
ENDOPLUS; Precision Laparoscopic Instruments; REF 346VA; Description 5mm Atraumatic Grasper S/A, Standard; Non-sterile; Manufactured by Endoplus; 750 Tower Rd., Suite A, Mundelein, IL 60060 USA. Intended for grasping, dissecting, retraction, clamping in conjunction with the laparoscopic during laparoscopic surgery.
Z-2264-2013
Product summary
- Firm
- Endoplus, Inc.
- Event
- Event 66063
- Status
- Terminated
- Classification
- Class II
- Quantity
- 81 units
- Official record key
device-enforcement:Z-2264-2013
Official wording
Reason: Multiple complaints reporting that the moveable jaw has broken during laparoscopic procedures.
Code information: Item: 346VA; Lot Numbers: D3, E3, F3
Distribution pattern: Distributed in the states of FL, TX, and VA.
Derived failure modes
-
Unknown
Multiple complaints reporting that the moveable jaw has broken during laparoscopic procedures.