BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON 60 ENDOPATH STAPLER

    MDR report key: 3920091 · Received July 8, 2014

    Report

    Report Number
    3005075853-2014-04764
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 7, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: DAMAGED FIRING SHUTTLE, PREMATURE SLED MOVEMENT. THE ANALYSIS RESULTS FOUND THAT ONE DEVICE WAS RETURNED WITH THE FIRING MECHANISM DAMAGED AND WITH TWO CARTRIDGE RELOADS PRESENT. THE RELOADS WERE RECEIVED PARTIALLY FIRED 1/16. IT IS POSSIBLE THAT WHILE LOADING THE RELOAD, THE CARTRIDGE WAS PUSHED FARTHER BACK THAN THE CARTRIDGE ALIGNMENT STOP WINDOWS RESULTING IN THE KNIFE PUSHING THE ONE PIECE SLED FORWARD AND LOCKING THE CARTRIDGE. DUE TO THE CONDITION OF THE DEVICE NO FUNCTIONAL TEST WAS PERFORMED. THE DEVICE WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS AND THE FIRING SHUTTLE WAS NOTED TO BE DAMAGED, CAUSING THE FIRING MECHANISM NOT TO PROPERLY OPERATE. THE DAMAGE TO THE FIRING SHUTTLE IS CONSISTENT WITH HIGH FORCES APPLIED WHEN CLAMPING OVER HARD OBJECTS AND OR THICKER TISSUE THEN INDICATED. WHEN PLACING THE INSTRUMENT ON THE TISSUE TO BE STAPLED, ENSURE THAT NO HARD OBSTRUCTION (SUCH AS A CLIP) IS INCLUDED WITH THE TISSUE INSIDE THE JAWS. 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. THE MANUFACTURING RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE COULD NOT FIRE AT THE THIRD STROKE OF THE FIRST FIRING WITH ECR60. THE FIRING TRIGGER WAS FLOPPY. CHANGED ANOTHER RELOAD BUT STILL HAD THE SAME ISSUE. CHANGED TO A NEW DEVICE AND RELOAD TO COMPETE THE PROCEDURE. NO ADVERSE EVENT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396198 ECHELON 60 ENDOPATH STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOAD ECR60D