BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 1080357 · Received July 24, 2008

    Report

    Report Number
    3005075853-2008-00367
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    June 17, 2008
    Report Date
    June 17, 2008
    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
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE ANALYSIS RESULTS FOR THE EL5ML INSTRUMENT CONFIRMED THAT IT WAS NON-FUNCTIONAL AS THE ANTI-BACKUP WAS NOTED TO BE DAMAGED. THE INSTRUMENT WAS CYCLED AND ADVANCED THE CLIPS INTO THE JAWS BUT THE CLIPS WERE NOT PROPERLY FORMED DUE TO THE CONDITION OF THE ANTI-BACKUP. HOWEVER, THE JAWS OPENED AND CLOSED AS INTENDED. UPON DISASSEMBLY, THE RATCHET PAWL FOUND TO BE WORN OUT CAUSING THE ANTI-BACKUP FAILURE. WE HAVE DOCUMENTED THE CIRCUMSTANCES AS THEY WERE REPORTED TO US. COMPLAINT INFO IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED. A BATCH HISTORY REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. THE CLIP APPLIER WAS PLACED THROUGH THE TROCAR, TRIGGER SQUEEZED DOWN AND JAWS STAYED CLOSED. THE JAWS SLIPPED OFF THE TISSUE AND NO CLIP WAS APPLIED, JAWS STAYED CLOSED THROUGHOUT THE PROCEDURE. WHEN TRIGGER FLIPPED BACK NO CLIP WAS APPLIED. TRIED AGAIN AND A "CRUNCH" WAS HEARD BUT STILL JAW REMAINED CLOSED. DEVICE REMOVED FROM THE ROOM, RN BANGED IT AROUND AND IN THE BIOHAZARD BAG IT WAS NOTICED THE JAW WAS OPENED AND WHEN THE TRIGGER WAS PULLED, IT FORMED THE CLIPS AND ARE IN THE BAG. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM ENDO CLIP APPLIER NONE FZP ETHICON ENDO-SURGERY, LLC NA E4KT32

    Patients

    Seq Age Sex Outcome Treatment
    1