BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETS FLEX ARTICNG

    MDR report key: 2002575 · Received February 28, 2011

    Report

    Report Number
    3005075853-2011-00762
    Event Type
    Malfunction
    Date Received
    February 28, 2011
    Date of Event
    January 17, 2011
    Report Date
    January 17, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PINION AXLE THE ANALYSIS RESULTS FOUND THAT THE ATS45 DEVICE WAS RECEIVED WITH THE FIRING MECHANISM DAMAGED AND WITH A RELOAD LOADED IN THE DEVICE. THE RELOAD WAS RECEIVED PARTIALLY WHICH INDICATES THAT THE DEVICE'S FIRING CYCLE WAS INTERRUPTED. NO FUNCTIONAL TEST COULD BE PERFORMED DUE TO THE CONDITION OF THE DEVICE. THE DEVICE WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS AND THE LEFT PINION AXEL SUPPORT WAS FOUND BROKEN. WHILE NO CONCLUSION COULD BE REACH ON WHAT CAUSE THE FIRING MECHANISM TO FAIL, IT IS POSSIBLE THAT THE DEVICE WAS ATTEMPTED TO FIRE ON TICKER TISSUE THEN INDICATED CAUSING AN INCREASE OF THE INTERNAL FORCES RESULTING IN THE COMPONENT YIELDING. 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. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TOTAL ABDOMINAL HYSTERECTOMY PROCEDURE, THE DEVICE WAS NOT CUTTING PROPERLY AND THE STAPLES WERE NOT WORKING. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES REPORTED. NO DETAILS ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETS FLEX ARTICNG STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK G4TK23

    Patients

    Seq Age Sex Outcome Treatment
    1