BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 1130390 · Received August 20, 2008

    Report

    Report Number
    3005075853-2008-01310
    Event Type
    Malfunction
    Date Received
    August 20, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 10, 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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANTIBACKUP. EVALUATION SUMMARY: THE ANALYSIS RESULTS FOR THE EL5ML INSTRUMENT CONFIRMED THAT IT WAS NON-FUNCTIONAL. THE INSTRUMENT WAS CYCLED AND FIRED 1 DOUBLE FEED, 9 CLIPS CONFORMING AND TWO MALFORMED CLIPS DUE TO AN ANTIBACKUP FAILURE. THE DEVICE WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS AND THE RATCHET PAWL WAS FOUND TO BE DAMAGED CAUSING THE ANTI-BACKUP FAILURE. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE DOUBLE FEED ISSUE. 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 RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MFG PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING LAP CHOLECYSTECTOMY PROCEDURE THE DEVICE WOULD NOT FIRE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE NURSE STATED THAT THE DEVICE JAMMED PRIOR TO USE ON THE PT. THERE WAS NO ADVERSE CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM ENDO CLIP APPLIER FZP ETHICON ENDO-SURGERY, LLC NA E4KX1J

    Patients

    Seq Age Sex Outcome Treatment
    1