BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAPLE, IMPLANTABLE

    MDR report key: 4243421 · Received November 11, 2014

    Report

    Report Number
    3005075853-2014-07811
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    September 23, 2014
    Report Date
    September 24, 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
    GA, 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 PSE60A DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH NO CARTRIDGE LOADED ON THE DEVICE. THE MANUAL OVERRIDE DOOR WAS NOTED TO BE OUT OF POSITION; 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. 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 VATS PROCEDURE WHEN THE DEVICE WAS OPEN FROM THE PACKAGE IT WAS DEFECTIVE. THE INFORMATION WAS LEFT IN AN EMAIL AND NO DETAILS WERE GIVEN TO THE REP. THERE IS NO INFORMATION ON HOW THE CASE WAS COMPLETED OR IF THE DEVICE WAS EVER USED ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725698 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK L424W

    Patients

    Seq Age Sex Outcome Treatment
    1