BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 3941870 · Received June 3, 2014

    Report

    Report Number
    2134070-2014-00114
    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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE INVESTIGATION FOUND THAT THE DEVICE WAS RETURNED IN GOOD VISUAL CONDITION WITH NO USABLE CLIPS REMAINING. THE LAST CLIP, WHICH IS NOT DESIGNED TO BE USED, WAS ADVANCED PARTIALLY INTO THE JAW. THE JAW APPEARED TO BE IN ALIGNMENT AND THE CLIP RETAINER, PUSH FORK AND JAW CLEARANCE APPEARED TO BE ACCEPTABLE. UPON EVALUATION, THE LOCKING MECHANISM WAS FOUND TO BE ENGAGED AS INTENDED. NO LOT NUMBER WAS PROVIDED, SO THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. AS THE RETURNED HAD NO USABLE CLIPS, THE COMPLAINT COULD NOT BE CONFIRMED.

    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 THIRD DEVICE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO ADDITIONAL INFORMATION WAS RECEIVED. A SUPPLEMENTAL REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323389 NA NMJ STERILMED, INC. ETHER320

    Patients

    Seq Age Sex Outcome Treatment
    1