BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLIP, IMPLANTABLE, REPROCESSED

    MDR report key: 4152557 · Received October 6, 2014

    Report

    Report Number
    2134070-2014-00175
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Date of Event
    September 10, 2014
    Report Date
    September 11, 2014
    Manufacturer
    STERILMED, INC.
    Product Code
    NMJ
    PMA / PMN Number
    K033579
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER AS OF THE DATE OF THIS REPORT AND WAS REPORTED TO HAVE BEEN DISCARDED BY THE USER FACILITY. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO DISCREPANCIES WERE NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WOULD NOT HOLD A CLIP/THE CLIP WOULD NOT HOLD TISSUE AND WAS MISFIRING. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY. IT WAS LATER REPORTED THAT DURING A GALLBLADDER REMOVAL THE TRIGGER OF THE DEVICE WAS STIFF AND AN AUDIBLE GRINDING NOISE WAS HEARD. THE HANDLE WAS NOT SMOOTH. WHEN THE HANDLE WAS CLOSED, THE CLIP CROSSED OVER ITSELF ON THE DUCT. THE ISSUE WAS NOTICED IMMEDIATELY. A CLIP WAS FULLY ADVANCED IN THE JAWS PRIOR TO FIRING. IT WAS NOT BELIEVED THAT ANY CLIPS WERE FIRED SUCCESSFULLY PRIOR TO THE EVENT. THE CLIP WAS NOT FIRED OVER ANOTHER CLIP OR HARD STRUCTURE. THE PATIENT WAS MIDDLE AGED, AND HEAVY SET. THE DEVICE WAS REPORTED TO BE DISCARDED BY THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622298 CLIP, IMPLANTABLE, REPROCESSED NMJ STERILMED, INC. ETHER320 1780559

    Patients

    Seq Age Sex Outcome Treatment
    1