BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 3950761 · Received June 9, 2014

    Report

    Report Number
    2134070-2014-00120
    Event Type
    Malfunction
    Date Received
    June 9, 2014
    Date of Event
    May 17, 2014
    Report Date
    May 19, 2014
    Manufacturer
    STERILMED, INC.
    Product Code
    NMJ
    PMA / PMN Number
    K033579
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE INVESTIGATION FOUND THAT THE DEVICE WAS RETURNED WITH A CLIP IN THE JAW NOT PROPERLY ALIGNED, POSSIBLY DUE TO TRANSPORT OR USE. THE JAW APPEARED TO BE IN ALIGNMENT AND THE CLIP RETAINER, PUSH FORK AND JAW CLEARANCE WERE ACCEPTABLE. UPON EVAL, THE CLIP RETURNED IN THE JAW, AND THE OTHER EIGHT REMAINING CLIPS WERE FIRED. THE CLIP THAT WAS MISALIGNED IN THE JAW WAS TWISTED AFTER FIRING. THE REMAINING EIGHT CLIPS WERE CYCLED, FED AND FORMED AS INTENDED WITH PROPER PINCH AND ALIGNMENT. AFTER THE LAST CLIP WAS FIRED, THE LOCKING MECHANISM ENGAGED AS DESIGNED. AS THE DEVICE PERFORMED AS INTENDED AFTER THE FIRST MISALIGNED CLIP WAS REMOVED, 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 TWO DEVICES WERE "TWISTING STAPLES." NO CLIPS WERE SUCCESSFULLY FIRED PRIOR TO THE EVENTS. THERE WAS NO TORQUING/TWISTING OR RESISTANCE FELT WHEN FIRING THE DEVICE. THERE WERE NO UNEXPECTED NOISES OR FEEDING ISSUES. CHOLANGIOGRAM WAS NOT DONE. THE TWISTING ISSUE OCCURRED ON THE FIRST FIRING OF BOTH DEVICES. ON THE SECOND FIRING OF THE FIRST DEVICE, THREE CLIPS CAME OUT AT ONCE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PT INJURY. THIS REPORT IS BEING FILED FOR THE FIRST DEVICE. SEE MFR REPORT #: 2134070-2014-00116 REGARDING THE SECOND DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334990 NA NMJ STERILMED, INC. ETHER320

    Patients

    Seq Age Sex Outcome Treatment
    1