FDA Adverse Event Malfunction Summary report: N

LIGAMAX-5MM ENDO CLIP APPLIER

MDR report key: 1915629 · Received December 6, 2010

Report

Report Number: 3005075853-2010-06892
Event Type: Malfunction
Date Received: December 6, 2010
Date of Event: October 20, 2010
Report Date: October 21, 2010
Manufacturer: ETHICON ENDO-SURGERY, LLC.
Product Code: FZP
PMA / PMN Number: K050344
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MO, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE ANALYSIS RESULTS OF THE DEVICE FOUND THAT IT WAS RECEIVED IN GOOD VISUAL CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON FIRING, THE TIP OF THE ADVANCER SLID TOWARD THE TISSUE STOP DURING THE CONSECUTIVE FIRING SEQUENCES CAUSING THE JAWS REMAINED IN THE CLOSED POSITION. THE TRIGGER WAS MANUALLY ASSISTED IN ORDER TO OPEN THE JAWS WITHOUT ANY DIFFICULTIES; PEAR SHAPED CLIPS WERE RELEASED. DURING THE NEXT FIRING SEQUENCE THE CLIP WAS FORMED AS CONFORMING. THE DEVICE LOCKED OUT AS INTENDED BUT THE ORANGE INDICATOR WAS OVERTRAVELED. AN INVESTIGATION WAS INITIATED TO ADDRESS THE POTENTIAL ROOT CAUSE OF JAW OPENING ISSUES. DURING THIS INVESTIGATION ADVANCER BYPASS WAS IDENTIFIED AS ONE POTENTIAL ROOT CAUSE; THEREFORE, ADVANCER BYPASS IS BEING EVALUATED IN THIS INVESTIGATION. THE FINAL QUALITY RELEASE CRITERIA WERE MET BEFORE THIS BATCH WAS RELEASED FOR DISTRIBUTION.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DEVICE MALFUNCTIONED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	LIGAMAX-5MM ENDO CLIP APPLIER	CLIP, IMPLANTABLE	FZP	ETHICON ENDO-SURGERY, LLC.	NA	G4TT5Z

Patients

Seq	Age	Sex	Outcome	Treatment
1