LIGACLIP ALLPORT ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER
Received Jun 26, 2008 · Event occurred May 31, 2008
Report 1527736-2008-03773 · MDR key 1068993
Device
Product problems
- Replace
- Failure to Form Staple
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED BY THE AFFILIATE DURING AN UNK PROCEDURE THAT THE DEVICE DELIVERED MALFORMED STAPLES. ANOTHER LIKE DEVICE WAS USED. THERE WAS NO PT CONSEQUENCE. ONE DEVICE RETURNING.
Additional Manufacturer Narrative
DAMAGED KICK OFF SPRING, BROKEN FEED CAM. EVALUATION SUMMARY: THE ANALYSIS RESULTS CONFIRMED THAT ONE AL326 DEVICE WAS RECEIVED WITH THE KICK OFF PROTRUDING FROM THE JAWS. WHEN TESTING THE DEVICE FOR FUNCTIONALITY, IT WOULD NOT FEED THE CLIPS. THE INSTRUMENT WAS DISASSEMBLED TO EXAMINE THE CONDITION OF THE INTERNAL COMPONENTS AND THE FEED CAM WAS NOTED TO BE BROKEN THEREFORE, THE ANTI BACKUP WOULD NOT WORK MAKING THE INSTRUMENT NONFUNCTIONAL. WE HAVE DOCUMENTED THE CIRCUMSTANCES AS THEY WERE REPORTED TO US. IN ADDITION, COMPLAINT INFO IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.