BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 2960470 · Received January 25, 2013

    Report

    Report Number
    2134070-2013-00018
    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 WAS RETURNED WITH A CLIP IN THE CLIP RETAINER OF THE DEVICE AND PARTIALLY MALFORMED IN A PEAR SHAPE BY THE JAWS, BUT NOT EXITING INTO THE JAWS. THE HANDLE OF THE DEVICE WAS NOTICEABLY DAMAGED WITH ONE SIDE OF THE TRIGGER HAVING COME OFF OF THE AXEL UPON WHICH THE HANDLE PIVOTS TO OPERATE THE DEVICE. THE DEVICE WAS ACTUATED, REQUIRING SO MUCH FORCE THAT THE HANDLE BROKE DURING TESTING. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE NOTED. AS EACH DEVICE IS VISUALLY AND FUNCTIONALLY TESTED PRIOR TO BEING RELEASED, 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 SECOND DEVICE. ADD'L INFO WAS REQUESTED, BUT NO ADD'L INFO WAS AVAILABLE. SEE MFR REPORT #2134070-2013-00017 REGARDING THE FIRST DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35466 NA NMJ STERILMED, INC. ETHMCL20

    Patients

    Seq Age Sex Outcome Treatment
    1