MalfunctionGDO
LIGACLIP ENDOSCOPIC SINGLE CLIP APPLIER
Received Jul 2, 1998 · Event occurred Jun 1, 1998
Report 1527736-1998-01908 · MDR key 175764
Device
Product problems
- Loose
- Replace
Patient
UNKNOWN
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED BY THE REP THAT THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. IT WAS REPORTED THAT THE EL314 CLIP APPLIER WOULD NOT HOLD THE CLIP. ANOTHER EL314 WAS OPENED TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PT. NO DR NAME AVAILABLE DUE TO INSTRUMENT BEING LEFT IN CSR ACCORDING TO REP.
Remedial action
- Other