BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** ETS FLEX45

    MDR report key: 2172987 · Received July 23, 2011

    Report

    Report Number
    3005075853-2011-02945
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Date of Event
    May 16, 2011
    Report Date
    May 24, 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
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FIRING TRIGGER TEETH. THE ANALYSIS RESULTS FOUND THAT THE ATW45 DEVICE WAS RECEIVED WITH THE FIRING MECHANISM DAMAGED AND WITH A RELOAD LOADED IN THE DEVICE. THE RELOAD WAS RECEIVED FULLY LOADED WITH STAPLES. NO FUNCTIONAL TEST COULD BE PERFORMED ON THE RETURNED DEVICE, HOWEVER, THE RELOAD WAS TESTED FOR FUNCTIONALITY WITH A TEST DEVICE. THE DEVICE FIRED, CUT, AND FORMED THE STAPLES AS INTENDED. THE DEVICE WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS AND THE FIRING TRIGGER TEETH WERE FOUND BROKEN. WHILE NO CONCLUSION COULD BE REACHED AS TO WHAT CAUSED THE FIRING MECHANISM TO FAIL, IT IS POSSIBLE THAT THE DEVICE WAS FIRED ON TISSUE THICKER THAN INDICATED OR THROUGH A LOCKED CARTRIDGE IN PREVIOUS FIRINGS. WHEN EITHER OR BOTH OF THESE SCENARIOS OCCUR THE COMPONENTS IN THE FIRING MECHANISM CAN BE DAMAGED. IT SHOULD BE NOTED THAT A 100% INSPECTION TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRE SPECIFICATIONS; IN ADDITION, A SAMPLE OF THE BATCH IS INSPECTED AT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP RECTUM PROCEDURE, THE INSTRUMENT DIDN'T FIRE. THE WHITE RELOAD PRESENT IN THE INSTRUMENT WAS CHANGED TO A NEW, GREEN RELOAD; HOWEVER, IT DIDN`T FIRE AS WELL. SURGERY WAS FINISHED WITH ANOTHER INSTRUMENT. SURGERY WAS PROLONGED TEN MINUTES. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH** ETS FLEX45 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK H43A5T

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOAD-TR45G