BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX45 ARTICULATING

    MDR report key: 2042560 · Received April 6, 2011

    Report

    Report Number
    3005075853-2011-01387
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    March 11, 2011
    Report Date
    March 14, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS FOUND THAT ONE (B)(4) DEVICE WAS RETURNED LOCKED IN GOOD VISUAL CONDITION, WITH A BLUE RELOAD PRESENT, AND WITH AN APPLIED TROCAR ON THE DEVICE. THE RELOAD WAS NOTED TO BE FULLY FIRED. IT SHOULD BE NOTED THAT THE DEVICE IS EQUIPPED WITH A SAFETY FEATURE TO LOCK THE DEVICE WHEN ATTEMPTING TO FIRE THE DEVICE WITHOUT A RELOAD, A PARTIALLY OR FULLY FIRED RELOAD. IN ORDER TO OPEN A LOCKED DEVICE 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 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. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP THAT DURING A PROCEDURE, AFTER FIRING THE ARTICULATED DEVICE ACROSS THE APPENDIX WITH A BLUE LOAD, THE DEVICE WOULD NOT OPEN THEREFORE WOULD NOT DE-ARTICULATE. THE SURGEON REMOVED THE ARTICULATED STAPLER WITH THE TROCAR FROM THE ABDOMEN AND PLACED A DIFFERENT TROCAR IN THE DEFECT. ANOTHER TROCAR WAS PLACED AND THERE WAS NO NEED FOR ANOTHER STAPLER, NO ADVERSE PATIENT OUTCOME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1