BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAPLE, IMPLANTABLE

    MDR report key: 4243375 · Received November 11, 2014

    Report

    Report Number
    3005075853-2014-07806
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    September 24, 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. THE ANALYSIS FOUND THAT ONE PSE45A DEVICE WAS RECEIVED FOR ANALYSIS WITHOUT CARTRIDGE RELOAD. FURTHERMORE, THE DEVICE WAS FOUND TO HAVE THE CLAMPING MECHANISM DAMAGED. IN ORDER TO EVALUATE THE CONDITION OF THE INTERNAL COMPONENTS, THE DEVICE WAS DISASSEMBLED. UPON DISASSEMBLING, THE CLAMP ARM RELEASE AND RELEASE BUTTON WERE NOTED WORN AND DAMAGED IN THE AREA WHERE BOTH INTERACT. THIS DAMAGE SUGGESTS THE DEVICE WAS FORCED TO OPEN WITH THE KNIFE NOT IN THE HOME POSITION BY PULLING THE CLOSING TRIGGER TO HOME. TO OPEN THE JAWS, SQUEEZE THE CLOSING TRIGGER, AND THEN SIMULTANEOUSLY PRESS THE ANVIL RELEASE SWITCH ON EITHER SIDE OF THE INSTRUMENT. WHILE PRESSURE IS STILL ON THE ANVIL RELEASE SWITCH, SLOWLY RELEASE THE CLOSING TRIGGER. NO FURTHER FUNCTIONAL TEST COULD BE PERFORMED DUE TO THE CONDITION OF THE DEVICE. HOWEVER A DRY FIRE WAS PERFORMED AND THE FIRING MECHANISM WORKED AS INTENDED. IT SHOULD BE NOTED THAT AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING MANUFACTURING TO ENSURE THAT THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT.

    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
    726105 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1