BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX60 LONG

    MDR report key: 2110007 · Received June 1, 2011

    Report

    Report Number
    3005075853-2011-02218
    Event Type
    Malfunction
    Date Received
    June 1, 2011
    Date of Event
    May 13, 2011
    Report Date
    May 13, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K081146
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): CLOSURE TRIGGER, RELEASE BUTTON THE (B)(4) DEVICE (A) WAS RECEIVED FOR ANALYSIS WITH THE RELEASE BUTTON BROKEN AND WITHOUT A RELOAD PRESENT. THE DEVICE WAS TESTED FOR FUNCTIONALITY IN THE ARTICULATED POSITION WITH A TEST CARTRIDGE AND ACHIEVED ITS COMPLETE FIRING SEQUENCE. THE STAPLE LINE AND CUT LINE WERE COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORM SHAPE. THE DEVICE WAS DISASSEMBLED TO VERIFY THE INTEGRITY OF THE INTERNAL COMPONENTS AND THE RELEASE BUTTON, CLOSURE TRIGGER TOP WERE NOTED TO BE DAMAGED. ONE POSSIBLE SCENARIO FOR THE DESCRIBED EVENT IS DUE TO APPLYING A LARGE PRYING FORCE ON THE CLOSURE TRIGGER HANDLE IN THE OPENING DIRECTION. THIS CAN THEN RESULT IN DAMAGE TO THE CLOSURE TRIGGER TOP COMPONENT AND RELEASE BUTTON IF THE APPLIED LOAD IS HIGH ENOUGH. 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 (B)(4) DEVICE (B) WAS RECEIVED FOR ANALYSIS WITH THE ANVIL CLOSED AND WITH AND GREEN RELOAD PRESENT. THE CARTRIDGE WAS RECEIVED PARTIALLY FIRED 1/10. IT IS POSSIBLE THAT WHILE LOADING THE RELOAD, IT WAS PUSHED FARTHER BACK THAN THE CARTRIDGE ALIGNMENT STOP WINDOWS RESULTING IN THE KNIFE PUSHING THE ONE PIECE SLED FORWARD AND LOCKING THE CARTRIDGE. IN ORDER TO OPEN A DEVICE WITH THE INDICATOR IN THE LOCKED POSITION A REVERSE STROKE NEEDS TO BE PERFORMED TRIGGER TO TRIGGER IN ORDER TO RETURN THE KNIFE TO THE HOME POSITION (INDICATOR IN THE "0" POSITION) AND PRESS THE ANVIL RELEASE BUTTON TO OPEN. ONCE THE DEVICE IS OPENED THE DEVICE CAN BE DE-ARTICULATED. THE DEVICE WAS TESTED FOR FUNCTIONALITY IN THE ARTICULATED POSITION WITH A TEST CARTRIDGE AND ACHIEVED ITS COMPLETE FIRING SEQUENCE. THE STAPLE LINE AND CUT LINE WERE COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORM SHAPE. THE DEVICE WAS DISASSEMBLED TO VERIFY THE INTEGRITY OF THE INTERNAL COMPONENTS AND THE RELEASE BUTTON, CLOSURE TRIGGER TOP WERE NOTED TO BE DAMAGED. ONE POSSIBLE SCENARIO FOR THE DESCRIBED EVENT IS DUE TO APPLYING A LARGE PRYING FORCE ON THE CLOSURE TRIGGER HANDLE IN THE OPENING DIRECTION. THIS CAN THEN RESULT IN DAMAGE TO THE CLOSURE TRIGGER TOP COMPONENT AND RELEASE BUTTON IF THE APPLIED LOAD IS HIGH ENOUGH. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE ON THE FIRST FIRING WITH A WHITE CARTRIDGE. THE DEVICE WAS FIRED AND THEN WOULD NOT OPEN. THE SURGEON USED SOMETHING TO PRY THE RELEASE BUTTON AND THE RELEASE KNOB CAME OFF AND THE DEVICE OPENED. THE RELEASE BUTTON WAS RETRIEVED FROM THE PATIENT. A SECOND DEVICE WAS PULLED AND LOADED WITH A WHITE CARTRIDGE. THE DEVICE WAS CLOSED AND INSERTED THROUGH THE TROCAR. THE DEVICE WOULD NOT OPEN. A COMPETITOR'S DEVICE WAS OPENED AND FIRED TWO TIMES. THE REP CAME INTO THE ROOM WITH A THIRD DEVICE AND THE SURGEON FIRED THE DEVICE TWELVE TIMES WITH NO ISSUE. THE CASE WAS COMPLETED WITH NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON*FLEX60 LONG STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK H43H79

    Patients

    Seq Age Sex Outcome Treatment
    1