BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 4001823 · Received June 3, 2014

    Report

    Report Number
    2134070-2014-00113
    Event Type
    Malfunction
    Date Received
    June 3, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 14, 2014
    Manufacturer
    STERILMED, INC.
    Product Code
    NMJ
    PMA / PMN Number
    K033579
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE INVESTIGATION FOUND THAT THE DEVICE WAS RETURNED WITH A CRACK ALONG THE SEAM OF THE HANDLE. THE JAW WAS IN ALIGNMENT AND THE CLIP RETAINER, PUSH FORK AND JAW CLEARANCE WERE ACCEPTABLE. UPON EVALUATION, IT WAS DETERMINED THAT THERE WERE NO REMAINING USABLE CLIPS IN THE DEVICE. THE LOCKING MECHANISM WAS ENGAGED AS INTENDED. IT WAS NOTED THAT THE ROTATION KNOB DID NOT SPIN FREELY AND WAS STIFF/TIGHT. NO LOT NUMBER WAS PROVIDED, SO THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY THE CLIPS FROM THREE DEVICES DID NOT FORM PROPERLY AND WASHED OFF THE ARTERY. THEY DID NOT COMPLETELY CLOSE AND LEFT A LOOP AT THE BEND AREA. CLIPS HAD BEEN FIRED SUCCESSFULLY FROM ONE OR MORE OF THE DEVICES. THERE WAS NO TORQUING OR TWISTING OF THE DEVICES AT THE TIME OF FIRING AND THERE WAS NO UNEXPECTED RESISTANCE FELT WHILE FIRING. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THIS REPORT IS FOR THE SECOND DEVICE. ADDITIONAL INFO WAS REQUESTED, BUT NO ADDITIONAL INO WAS RECEIVED. A SUPPLEMENTAL REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323290 NA NMJ STERILMED, INC. ETHER320

    Patients

    Seq Age Sex Outcome Treatment
    1