BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETS-FLEX - ENDOSCOPIC

    MDR report key: 2153754 · Received July 8, 2011

    Report

    Report Number
    3005075853-2011-02796
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    May 3, 2011
    Report Date
    May 31, 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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FIRING TRIGGER TEETH. THE ANALYSIS RESULTS FOUND THAT ONE ATW35 DEVICE WAS RETURNED WITH THE SHROUDS OPENED AND THE FIRING MECHANISM DAMAGED AND WITH NO RELOAD PRESENT. 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 FIRING TRIGGER POST AND TEETH WERE FOUND BROKEN. WHILE NO CONCLUSION COULD BE REACH ON WHAT CAUSE THE FIRING MECHANISM TO FAIL AND THE SHROUDS TO BECOME OPENED, IT IS POSSIBLE THAT THE DEVICE WAS ATTEMPTED TO FIRE ON THICKER TISSUE THEN INDICATED CAUSING AN INCREASE OF THE INTERNAL FORCES RESULTING IN THE COMPONENT YIELDING. IT SHOULD BE NOTED THAT A 100% INSPECTIONS TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRE SPECIFICATIONS; (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A CYSTECTOMY PROCEDURE, THE DEVICE LOCKED OUT AND WOULD NOT FIRE. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETS-FLEX - ENDOSCOPIC STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK H4326M

    Patients

    Seq Age Sex Outcome Treatment
    1