BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 1191194 · Received October 9, 2008

    Report

    Report Number
    1527736-2008-03626
    Event Type
    Malfunction
    Date Received
    October 9, 2008
    Date of Event
    May 21, 2008
    Report Date
    May 21, 2008
    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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ANALYSIS RESULTS FOR THE EL5ML DEVICE FOUND THAT IT WAS RETURNED WITH THE CAM BROKEN. THE DEVICE WAS CYCLED AND EJECTED THE REMAINING CLIP DUE TO THE CAM CONDITION. IN ADDITION, THE ORANGE INDICATOR WAS NOTED TO BE BEYOND ITS INTENDED POSITION. WE HAVE DOCUMENTED THE CIRCUMSTANCES AS THEY WERE REPORTED TO US. IN ADDITION, 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 A LAP CHOLECYSTECTOMY PROCEDURE, WHEN THEY WENT TO FIRE THE DEVICE NOTHING HAPPENED. THEY GOT A NEW ONE TO COMPLETE THE PROCEDURE. THERE WAS NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM ENDO CLIP APPLIER NONE FZP ETHICON ENDO SURGERY, INC. (CINCINNATI) NA E4KP8P

    Patients

    Seq Age Sex Outcome Treatment
    1