BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 2960503 · Received January 25, 2013

    Report

    Report Number
    2134070-2013-00017
    Event Type
    Malfunction
    Date Received
    January 25, 2013
    Report Date
    January 14, 2013
    Manufacturer
    STERILMED, INC.
    Product Code
    NMJ
    PMA / PMN Number
    K033579
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE INVESTIGATION FOUND THAT THE DEVICE HANDLE HAD A VERY MINOR SEPARATION AT THE PROXIMAL END. UPON FUNCTIONAL EVAL, THE DEVICE WAS CYCLED, FED, AND FORMED THE REMAINING NINE CLIPS WITH PROPER PINCH AND ACCEPTABLE ALIGNMENT DESPITE THE MINOR DAMAGE TO THE HANDLE. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE NOTED. NO CONCLUSION COULD BE DRAWN AS TO WHAT MIGHT HAVE CAUSED THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE TWO DEVICES WERE "NOT CLIPPING TIGHTLY/MISFIRING." A THIRD DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PT INJURIES. IT WAS UNCLEAR WHETHER EACH DEVICE BOTH MISFIRED AND FAILED TO CLIP TIGHTLY. THIS REPORT IS FOR THE FIRST DEVICE. ADD'L INFO WAS REQUESTED, BUT NO ADD'L INFO WAS AVAILABLE. SEE MFR REPORT #2134070-2013-00018 REGARDING THE SECOND DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35419 NA NMJ STERILMED, INC. ETHMCL20

    Patients

    Seq Age Sex Outcome Treatment
    1