BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX60 ARTICULATING

    MDR report key: 1950694 · Received January 6, 2011

    Report

    Report Number
    1527736-2011-00009
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    December 3, 2010
    Report Date
    December 13, 2010
    Manufacturer
    ETHICON ENDO SURGERY, INC (CINCINNATI)
    Product Code
    GDW
    PMA / PMN Number
    K081146
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INCOMPLETE/INTERRUPTED FIRING CYCLE. THE EC60A 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 DEVICE IS OPENED, THEN CLOSED AND FIRING IS RESUMED, CAUSING THE INSTRUMENT TO LOCKOUT. 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. IT SHOULD BE NOTED THAT 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. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON*FLEX60 ARTICULATING STAPLE, IMPLANTABLE GDW ETHICON ENDO SURGERY, INC (CINCINNATI) UNK G4U12H

    Patients

    Seq Age Sex Outcome Treatment
    1