BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX60 LONG

    MDR report key: 2042539 · Received April 6, 2011

    Report

    Report Number
    3005075853-2011-01385
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    March 2, 2011
    Report Date
    March 14, 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
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LONG60A DEVICE WAS RECEIVED FOR ANALYSIS WITH NO VISUAL NON-CONFORMANCES AND WITH A CARTRIDGE RELOAD PRESENT. THE DEVICE WAS RETURNED WITH THE ANVIL AND CLOSING TRIGGER IN THE CLOSED POSITION AND THE FIRING MECHANISM ENGAGED AND ADVANCE PARTIALLY IN THE FIRST STROKE. THE CARTRIDGE RELOAD WAS RECEIVED PARTIALLY FIRED. IT SHOULD BE NOTED THAT IN ORDER TO OPEN A DEVICE THAT IS PARTIALLY FIRED, A REVERSE STROKE NEEDS TO BE PERFORMED IN ORDER TO OPEN THE DEVICE. THE DEVICE WAS TESTED FOR FUNCTIONALITY IN THE ARTICULATED POSITION USING 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. EVENT COULD NOT BE CONFIRMED AS THE DEVICE OPENED AND CLOSED AS INTENDED. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, ON THE THIRD FIRING, THE DEVICE WAS INSERTED INTO THE TROCAR THEN WOULD NOT OPEN TO PLACE ON THE TISSUE. THE DEVICE WAS NOT CLOSED ON TISSUE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1