BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON 60

    MDR report key: 2040151 · Received April 5, 2011

    Report

    Report Number
    3005075853-2011-01349
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    January 7, 2011
    Report Date
    January 12, 2011
    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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RELEASE BUTTON; INCOMPLETE/INTERRUPTED FIRING THE SC60 DEVICE WAS RECEIVED FOR ANALYSIS WITH NO VISUAL NON-CONFORMANCES AND WITH A CARTRIDGE RELOAD PRESENT. THE CARTRIDGE RELOAD WAS RECEIVED PARTIALLY FIRED. A PARTIAL FIRE CAN OCCUR IF THE FIRING SEQUENCE IS INTERRUPTED. 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 WAS DISASSEMBLED TO VERIFY THE INTEGRITY OF THE INTERNAL COMPONENTS AND THE RELEASE BUTTON WAS NOTED TO BE DAMAGED. THIS DAMAGE IS CONSISTENT WITH PARTIALLY ENGAGING THE ANVIL RELEASE BUTTON INADVERTENTLY AFTER CLOSING THE DEVICE BUT BEFORE FIRING. THIS CAUSES THE RELEASE BUTTON TO PARTIALLY ENGAGE WITH THE INDICATOR GEAR. AS A RESULT OF THIS CONDITION, WHEN ATTEMPTING TO FIRE, SIGNIFICANT RESISTANCE WILL BE FELT DUE TO THE FACT THAT THE RELEASE BUTTON IS BLOCKING THE PATH OF THE INDICATOR GEAR. IF THE FIRING STROKE IS CONTINUED PAST THIS POINT, THE INDICATOR GEAR PUSHES INTO ON THE RELEASE BUTTON, RESULTING IN DAMAGE OR BREAKAGE OF THE RELEASE BUTTON.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN OPEN TOTAL CYSTECTOMY PROCEDURE, THERE WAS NO FEEDBACK OF GRASPING THE FIRING TRIGGER AND THE KNIFE DID NOT MOVE FORWARD AT THE FIRST STROKE OF THE FIRST FIRING AFTER THE ALIMENTARY TACT WAS CLAMPED. THE SECOND CARTRIDGE WAS LOADED INTO THE SAME INSTRUMENT, BUT THE SAME EVENT OCCURRED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES 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 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOAD-(B)(4)