BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 3915357 · Received May 28, 2014

    Report

    Report Number
    2134070-2014-00105
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Report Date
    April 9, 2014
    Manufacturer
    STERILMED, INC.
    Product Code
    NMJ
    PMA / PMN Number
    K033579
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE INVESTIGATION FOUND THAT THE DEVICE WAS RETURNED IN GOOD VISUAL CONDITION WITH A CLIP SIDEWAYS IN THE JAW. THE CLIP WAS EASILY REMOVED, BUT HAD A "J" SHAPE. THE JAW WAS IN ALIGNMENT, AND THE CLIP RETAINER, PUSH FORK AND JAW CLEARANCE WERE ACCEPTABLE. UPON EVALUATION, THE REMAINING THREE CLIPS WERE FIRED FROM THE DEVICE AND HAD BOTH PROPER PINCH AND ALIGNMENT. AFTER THE LAST CLIP WAS FIRED, THE LOCKING MECHANISM ENGAGED, AS INTENDED. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO DISCREPANCIES WERE NOTED.

    Description of Event or Problem · 1

    DEVICE WAS RETURNED WITH NO INFORMATION AS TO THE FAILURE MODE. THERE WAS NO PATIENT INJURY. THIS REPORT IS BEING FILED FOR THE FINDINGS UPON INVESTIGATION. ADDITIONAL INFORMATION IS BEING REQUESTED. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314617 NA NMJ STERILMED, INC. ETHER420 1660140

    Patients

    Seq Age Sex Outcome Treatment
    1