BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 3810669 · Received March 24, 2014

    Report

    Report Number
    2134070-2014-00056
    Event Type
    Malfunction
    Date Received
    March 24, 2014
    Report Date
    February 28, 2014
    Manufacturer
    STERILMED, INC.
    Product Code
    NMJ
    PMA / PMN Number
    K033579
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    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, IT WAS FOUND THAT THE HANDLE LEVER DID NOT OPERATE PROPERLY, AS IF LOCKED. AFTER SEVERAL ATTEMPTS AND USE OF FORCE, THE LEVER WAS ABLE TO OPERATE. THE FIRST CLIP CAME OUT WITH PROPER PINCH AND ALIGNMENT, THE NEXT 12 CLIPS DID NOT LOAD INTO THE JAW PROPERLY AND CAME OUT SIDEWAYS AND NOT PINCHED. THE LAST CLIP LOADED PROPERLY AND HAD PROPER PUNCH AND ALIGNMENT. AFTER THE LAST CLIP WAS EXPELLED, THE LOCKING MECHANISM DID NOT ENGAGE AS INTENDED. NO JOB NUMBER WAS PROVIDED, SO THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED FOR DISCREPANCIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE THERE WAS A "SCISSOR CLIP." IT WAS LATER REPORTED THAT THE FIRST FIRED "STAPLE" LOCKED SIDEWAYS. THE NEXT TWO LOADED AND FIRED APPROPRIATELY. THE NEXT ONE JAMMED AND THE DEVICE LOCKED. UNABLE TO USE. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172858 NA NMJ STERILMED, INC. ETHER420

    Patients

    Seq Age Sex Outcome Treatment
    1