BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 3941855 · Received June 3, 2014

    Report

    Report Number
    2134070-2014-00112
    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 IN GOOD VISUAL CONDITION WITH A CLIP IN THE JAW. THE JAW APPEARED TO BE IN ALIGNMENT AND THE CLIP RETAINER, PUSH FORK AND JAW CLEARANCE WERE ACCEPTABLE. UPON EVALUATION, THE REMAINING SIX CLIPS WERE CYCLED, FED AND PRODUCED WITH PROPER PINCH AND ALIGNMENT. THE LOCKING MECHANISM DID NOT ENGAGE AFTER THE LAST CLIP WAS FIRED. NO LOT NUMBER WAS PROVIDED, SO THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. AS THE REMAINING CLIPS WERE PRODUCED AS DESIGNED, NO CONCLUSION COULD BE MADE AS TO WHAT MAY HAVE CAUSED THE REPORTED EVENT.

    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 FIRST 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
    324339 NA NMJ STERILMED, INC. ETHER320

    Patients

    Seq Age Sex Outcome Treatment
    1