FDA Adverse Event Malfunction Summary report: N

LIGAMAX-5MM ENDO CLIP APPLIER

MDR report key: 1820835 · Received August 16, 2007

Report

Report Number: 1527736-2007-05463
Event Type: Malfunction
Date Received: August 16, 2007
Date of Event: July 13, 2007
Report Date: July 25, 2007
Manufacturer: ETHICON ENDO-SURGERY, INC (CINCINNATI)
Product Code: FZP
PMA / PMN Number: K050344
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: KY, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). BROKEN CAM. EVALUATION SUMMARY: THE ANALYSIS RESULTS FOR THE EL5ML INSTRUMENT CONFIRMED THAT IT WAS RETURNED NON-FUNCTIONAL. THE INSTRUMENT WAS CYCLED AND A DOUBLE FED INCIDENT OCCURRED. SUBSEQUENT SIX FIRING WERE CONFORMING AND UPON THE EIGHT FIRING THE CAM BROKE. THE INSTRUMENT LOCKED OUT AS INTENDED. CORRECTIVE AND PREVENTIVE ACTION HAS BEEN INITIATED FOR THE BROKEN CAM AND DOUBLE FEEDING ISSUES. WE HAVE DOCUMENTED THE CIRCUMSTANCES AS THEY WERE REPORTED TO US. IN ADDITION, COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED. OUR MANUFACTURING BATCH HISTORY REVIEW IDENTIFIED THAT A DOUBLE FED ISSUE AND CLIPS WITH GAP WERE DETECTED DURING THE MANUFACTURING OF THIS BATCH. WHEN THIS OCCURS, OUR QUALITY SYSTEM DOCUMENTS THE NECESSARY ACTIONS TO ENSURE FINAL PRODUCT QUALITY. THE FINAL QUALITY RELEASE CRITERIA WAS MET BEFORE THIS BATCH WAS RELEASED FOR DISTRIBUTION.

Description of Event or Problem · 1

IT WAS REPORTED THEN WOULD NOT RELEASE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PATIENT. ONE DEVICE BEING RETURNED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	LIGAMAX-5MM ENDO CLIP APPLIER		FZP	ETHICON ENDO-SURGERY, INC (CINCINNATI)	NA	D4H73P

Patients

Seq	Age	Sex	Outcome	Treatment
1