BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAPLE, IMPLANTABLE

    MDR report key: 4192732 · Received October 22, 2014

    Report

    Report Number
    3005075853-2014-07292
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    August 25, 2014
    Report Date
    September 9, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K110385
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD THE INFORMATION BE PROVIDED LATER, A SUPPLEMENTAL MEDWATCH WILL BE SENT. PAWL THE ANALYSIS FOUND THAT ONE PLE60A DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH THE MANUAL OVERRIDE DOOR OUT OF POSITION AND MISSING; THE OVERRIDE LEVER WAS UP WHICH DENOTES THAT THE KNIFE WAS MANUALLY RETURNED TO HOME POSITION. IT SHOULD BE NOTED AFTER THE MANUAL OVERRIDE SYSTEM IS USED THE INSTRUMENT IS DISABLED AND CANNOT BE USED FOR ANY SUBSEQUENCE FIRINGS. AN ECR60T CARTRIDGE RELOAD WAS RECEIVED PARTIALLY FIRED 1/16 AND LOADED IN THE DEVICE. IT IS POSSIBLE THAT WHILE LOADING THE RELOAD, THE CARTRIDGE WAS PUSHED FARTHER BACK THAN THE CARTRIDGE ALIGNMENT STOP WINDOWS RESULTING IN THE KNIFE PUSHING THE ONE PIECE SLED FORWARD AND LOCKING THE CARTRIDGE. THE DEVICE WAS DISASSEMBLED TO RESET THE MANUAL OVERRIDE SYSTEM; THE INSTRUMENT WAS TESTED FOR FUNCTIONALITY IN THE STRAIGHT POSITION WITH A TEST CARTRIDGE RELOAD AND THEN, THE KNIFE ONLY ADVANCED A FEW MILLIMETERS AND THE FIRING STOPPED. THE KNIFE REVERSE BUTTON WAS ACTIVATED AND THE KNIFE RETURNED TO HOME AS INTENDED. IN ORDER TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS THE DEVICE WAS DISASSEMBLED. UPON DISASSEMBLING, THE PAWL BAILOUT WAS FOUND TO BE DAMAGED AND ENGAGED WITH THE DRIVE BAR. IT PREVENTED THE DEVICE FROM FIRING; HOWEVER, IT COULD NOT BE DETERMINED WHAT MAY HAVE CAUSED THIS CONDITION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SLEEVE PROCEDURE, THE DEVICE DID NOT FIRE, TRIED A NEW BATTERY AND IT DIDN'T WORK EITHER. THERE WERE NO PATIENT CONSEQUENCES. CASE COMPLETED WITH ANOTHER DEVICE OF THE SAME PRODUCT CODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673208 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1