BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX45 LONG

    MDR report key: 2082230 · Received May 9, 2011

    Report

    Report Number
    3005075853-2011-01882
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Date of Event
    April 13, 2011
    Report Date
    April 13, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS FOUND THAT ONE EC45AL DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH NO CARTRIDGE RELOAD LOADED ON THE DEVICE. THE DEVICE WAS TESTED FOR FUNCTIONALITY IN THE ARTICULATED POSITION WITH A TEST CARTRIDGE RELOAD AND ACHIEVED ITS COMPLETE FIRING SEQUENCE WITHOUT ANY DIFFICULTIES. THE STAPLE LINE AND CUT LINE WERE COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORM SHAPE. THE DEVICE OPENED AND CLOSED WITHOUT ANY DIFFICULTIES. IT SHOULD BE NOTED THAT 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. EVENT COULD NOT BE CONFIRMED AS THE DEVICE OPENED WITHOUT ANY DIFFICULTIES NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROBOTIC PROSTECTOMY PROCEDURE, THE PA FIRED THE DEVICE AND NOTICED EXCESSIVE FORCE TO PUSH THE RELEASE BUTTON. THE PA HAD TO USE TWO HANDS TO PUNCH THE BUTTON TO OPEN THE JAWS. THE SALES REP TOOK THE DEVICE OFF OF THE FIELD AFTER USE AND DRY FIRED THE DEVICE AND THE RELEASE BUTTON IS NOT THAT DIFFICULT IF THE GUN IS NOT CYCLED BUT AFTER CYCLING THE DEVICE IT REQUIRES MUCH FORCE TO PUSH THE RELEASE BUTTON. THE PA USED IT FOR ONE FIRING AND THE FIRING WAS COMPLETE AND HEMOSTATIC. THERE WERE NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON*FLEX45 LONG STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1