BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON 60

    MDR report key: 1891173 · Received November 4, 2010

    Report

    Report Number
    3005075853-2010-06302
    Event Type
    Malfunction
    Date Received
    November 4, 2010
    Date of Event
    October 12, 2010
    Report Date
    October 13, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). THE EC60 DEVICE WAS RECEIVED FOR ANALYSIS WITH NO VISUAL NON-CONFORMANCES AND WITH AN ECR60B CARTRIDGE RELOAD PRESENT. THE CARTRIDGE RELOAD WAS 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, LOCKING THE CARTRIDGE AND PUSHING STAPLES UPWARDS. THE RETURNED CARTRIDGE RELOAD WAS TESTED FOR FUNCTIONALITY BY RESETTING AND RELOADING IT INTO THE DEVICE. THE FUNCTIONAL TEST DEMONSTRATED THAT THE REMAINING STAPLES IN THE CARTRIDGE RELOAD FORMED PROPERLY AND THE INSTRUMENT ACHIEVED ITS COMPLETE 3-STROKE FIRING SEQUENCE WITHOUT ANY DIFFICULTIES. THE DEVICE OPENED AND CLOSED AS INTENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP ANTERIOR SIGMOID RESECTION PROCEDURE, ON THE 2ND FIRING OF THE DEVICE, ACROSS THE SIGMOID, THE SURGEON COULD NOT ADVANCE THE FIRING LEVER PAST THE 1ST STROKE. THE JAW COULD NOT BE OPENED BY PRESSING THE RELEASE BUTTON AND THE SURGEON HAD TO USE THE MANUAL RELEASE LEVER TO OPEN THE ANVIL. UPON INSPECTION IT WAS NOTED THAT THE STAPLES HAD BEEN PARTIALLY EXPELLED AND THE LEGS OF THE STAPLES WERE NOT FORMED. THE UNFORMED STAPLES WERE REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON 60 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK G4TE3Z

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR