BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 3908718 · Received May 5, 2014

    Report

    Report Number
    2134070-2014-00089
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Report Date
    February 26, 2014
    Manufacturer
    STERILMED, INC.
    Product Code
    NMJ
    PMA / PMN Number
    K033579
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE INVESTIGATION FOUND THAT THE DEVICE WAS RETURNED IN GOOD VISUAL CONDITION. THE JAW APPEARED TO BE IN ALIGNMENT, AND THE CLIP RETAINER, PUSH FORK AND JAW CLEARANCE WERE ACCEPTABLE. UPON EVAL, THE REMAINING ELEVEN CLIPS WERE CYCLED AND FED. ALL OF THE CLIPS LOADED PROPERLY INTO THE JAWS. SEVEN OF THE FIRED CLIPS HAD PROPER PINCH AND ALIGNMENT, BUT FOUR OF THE CLIPS WERE SLIGHTLY SCISSORED. AFTER THE LAST CLIP WAS FIRED, THE LOCKING MECHANISM ENGAGED AS INTENDED. THE LOT NUMBER WAS NOT PROVIDED, SO THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS MISFIRING. NO OTHER INFO WAS PROVIDED. ADD'L INFO WAS REQUESTED. BUT NO ADD'L INFO WAS AVAILABLE. A SUPPLEMENTAL REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269456 NA NMJ STERILMED, INC. ETHER420

    Patients

    Seq Age Sex Outcome Treatment
    1