BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 3894260 · Received February 19, 2014

    Report

    Report Number
    2134070-2014-00041
    Event Type
    Malfunction
    Date Received
    February 19, 2014
    Report Date
    December 20, 2013
    Manufacturer
    STERILMED, INC.
    Product Code
    NMJ
    PMA / PMN Number
    K033579
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE INVESTIGATION FOUND THAT THE DEVICE WAS RETURNED IN GOOD VISUAL CONDITION. THE JAWS WERE IN ALIGNMENT. THE CIP RETAINER AND PUSH FORK AND JAW CLEARANCE WERE ACCEPTABLE. UPON EVAL, THE THREE REMAINING CLIPS WERE FIRED FROM THE DEVICE. THE FIRST TWO CLIPS FIRED AT NORMAL SPEED AND HAD PROPER PINCH, BUT WERE SLIGHTLY SCISSORED. THE THIRD CLIP DID NOT LOAD PROPERLY IN THE JAW AND CAME OUT SIDEWAYS AND UNFORMED WHEN FIRED. THE LOCKING MECHANISM ENGAGED AS INTENDED WHEN ALL OF THE REMAINING CLIPS WERE FIRED, THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO DISCREPANCIES WERE NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN CLIP FIRED, IT CAME OUT BELOW NOT FOLLOWING ON TRACK. UNFORMED CLIPS WERE EJECTED. THERE WAS NO PT INJURY. THIS REPORT IS BEING FILED FOR THE FINDINGS UPON DEVICE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104363 NA NMJ STERILMED, INC. ETHER420 1693138

    Patients

    Seq Age Sex Outcome Treatment
    1