BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON 60 ENDOPATH

    MDR report key: 3192957 · Received June 27, 2013

    Report

    Report Number
    3005075853-2013-03313
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    June 7, 2013
    Report Date
    June 8, 2013
    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). INFORMATION WAS NOT PROVIDED BY THE AFFILIATE. THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RECEIVED FOR ANALYSIS; NO RELOAD WAS PRESENT. THE DEVICE WAS RECEIVED WITH THE ANVIL AND THE CLOSURE TRIGGER IN THE OPEN POSITION. UPON EVALUATION, THE DEVICE COULD NOT BE FIRED DUE TO THE KNIFE ONLY ADVANCED INTO LOCKOUT REGION. IN ORDER TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS THE INSTRUMENT WAS DISASSEMBLED. UPON DISASSEMBLING, ONE PLASTIC CLIP WAS FOUND LODGED INSIDE THE ANVIL KNIFE SLOT AT PROXIMAL END THIS, BLOCKED THE KNIFE TO MOVE UP AND JUMP THE LOCKOUT FEATURE TO CONTINUE ITS PATH FORWARD DURING FIRING. THE FOUND PLASTIC CLIP COULD JAM THE FIRING MECHANISM ON ITS RETURN TO HOME. IF THE KNIFE IS NOT IN HOME, THE DEVICE WOULD NOT OPEN. 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. PLEASE REFERENCE THE INSTRUCTION FOR USE FOR WARNINGS AND PRECAUTION REGARDING FIRING ACROSS HARD OBJECTS 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, THE JAW COULD NOT OPEN AFTER FIRING. THE SURGEON USING MANUAL FIRING RELEASE LEVER MORE THAN TEN MINUTES TO OPEN THE JAW. THE DEVICE WAS USED ON VESSEL, AND THE BLOOD FLOWED OUT AFTER THE DEVICE WAS REMOVED. THE SURGEON CHANGED HAND SEWING TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293880 ECHELON 60 ENDOPATH STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA K4C527

    Patients

    Seq Age Sex Outcome Treatment
    1