BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETS FLEX ARTICNG LNR CUTR

    MDR report key: 3181389 · Received June 21, 2013

    Report

    Report Number
    3005075853-2013-03162
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 23, 2013
    Report Date
    May 27, 2013
    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). INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. DAMAGED FIRING TRIGGER TEETH, DAMAGED YOKE TEETH, DAMAGED SHROUDS. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: "THE UROLOGY RESIDENT SAID THAT THEY WERE OPERATING ON A TUMOR IN THE BLADDER. THE TISSUE WAS TOO THICK TO USE THE DEVICE. NO ADDITIONAL DETAILS ON THE STAPLE DEPLOYMENT, OR HOW THE CASE WAS COMPLETED." THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RECEIVED WITH THE CLAMPING MECHANISM AND FIRING MECHANISM DAMAGED; THE HANDLE SHROUDS WERE NOTED SLIGHTLY SEPARATED. A TR45W CARTRIDGE WAS LOADED IN THE DEVICE, IT WAS FOUND UNFIRED. 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 YOKE TEETH AND FIRING TRIGGER TEETH WERE FOUND BROKEN. WHILE NO CONCLUSION COULD BE REACH ON WHAT CAUSE THE FIRING AND CLAMPING MECHANISMS TO FAIL, IT IS POSSIBLE THAT THE DEVICE WAS ATTEMPTED TO FIRE ON TICKER TISSUE THEN INDICATED OR ATTEMPTED TO FIRE TROUGH A LOCKED RELOAD IN PREVIOUS FIRINGS 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; IN ADDITION, A SAMPLE OF THE BATCH IS INSPECTED AT (B)(4). THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, ONLY PART OF THE STAPLES FIRED WITH THE BLUE CARTRIDGE (ONLY INFORMATION GIVEN). THERE WERE NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281682 ETS FLEX ARTICNG LNR CUTR STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1