WAVE SIDE GRASPER FORCEPS
Received Apr 7, 2010 · Event occurred Feb 22, 2010
Report 1418479-2010-00005 · MDR key 1655135
Device
Generic name
Wave Side Grasper Forceps
Manufacturer
Richard Wolf Medical InstrumentsModel number
8383.2937Catalog number
8383.2937
Lot number
1U03
Product problems
- Break
- Detachment Of Device Component
Patient
48 YR
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT WHILE USING THE GRASPER DURING A LAPAROSCOPIC SIGMOID RESECTION, THE JAW BROKE OFF INSIDE THE PATIENT. THE PIECE WAS RETRIEVED AND ACCOUNTED FOR BY THE SURGEON AND THE OR STAFF. THE JAW PIECE WAS DISCARDED. THERE WAS NO PATIENT INJURY.
Additional Manufacturer Narrative
JAW BROKEN. EVALUATION SUMMARY: VISUAL INSPECTION OF THE FORCEPS WITH BROKEN JAW SHOWED NO CORROSION AT THE POINT OF BREAKAGE. THE FORCEPS IS APPROXIMATELY 6 YEARS OLD. THE INSULATION IS IN GOOD CONDITION. OUR REPAIR RECORDS SHOW THAT THIS FACILITY PURCHASED A MORE THAN ONE OF THESE FORCEPS OF THIS LOT NUMBER 1U03 IN 2004. WE CONSIDER THIS AN ISOLATED OCCURRENCE SINCE NO OTHER COMPLAINTS OF THIS TYPE ARE IN THE SYSTEM. CAUSE OF EVENT: NORMAL WEAR AND TEAR FOR THIS PERIOD OF TIME IN USE.