BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 1081089 · Received July 21, 2008

    Report

    Report Number
    3005075853-2008-00607
    Event Type
    Malfunction
    Date Received
    July 21, 2008
    Date of Event
    April 24, 2008
    Report Date
    April 28, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 07/21/2008. EVAL SUMMARY: THE ANALYSIS RESULTS FOUND THAT THE EL5ML DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION. WHEN TESTING THE DEVICE FOR FUNCTIONALITY IT WAS NOTED TO BE EMPTY AND THE LOCKOUT WAS FIRED THROUGH. AS THE IFU STATES: "DO NOT ATTEMPT TO FIRE THROUGH THE LOCKOUT. IF THE TRIGGER IS FORCED CLOSED ONCE THE LAST CLIP LOCKOUT HAS ENGAGED, THE JAWS MAY REMAIN CLOSED". 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. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP CHOLE PROCEDURE, THE DEVICE WOULD NOT FIRE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM ENDO CLIP APPLIER FZP ETHICON ENDO-SURGERY, LLC NA E4KP1H

    Patients

    Seq Age Sex Outcome Treatment
    1