BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 3908720 · Received May 5, 2014

    Report

    Report Number
    2134070-2014-00090
    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 EVALUATION, THE CLIPS WERE CYCLED AND FED TO BE TEST FIRED. SIX OF THE CLIPS WERE CYCLED AND FED TO BE TEST FIRED. SIX OF THE CLIPS LOADED PROPERLY HAD PROPER PINCH AND ALIGNMENT. THREE OF THE CLIPS LOADED PROPERLY BUT WERE SLIGHTLY SCISSORED. AFTER THE NINTH CLIP WAS FIRED, THE REMAINING CLIPS WOULD NO LONGER LOAD INTO THE JAW. 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. ADDITIONAL INFO WAS REQUESTED, BUT NO ADDITIONAL INFO WAS AVAILABLE. A SUPPLEMENTAL REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268707 NA NMJ NMJ STERILMED, INC. ETHER420

    Patients

    Seq Age Sex Outcome Treatment
    1