BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX60

    MDR report key: 1981745 · Received February 8, 2011

    Report

    Report Number
    1527736-2011-00038
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    December 3, 2010
    Report Date
    December 7, 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
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS FOUND THAT ONE EC60A DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH ONE ECR60W CARTRIDGE RELOAD LOADED IN THE DEVICE. THE CARTRIDGE RELOAD WAS RECEIVED FULLY FIRED. 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 BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC HEPATECTOMY PROCEDURE, THE SURGEON COULD NOT FIRE THE DEVICE. THE SURGEON RELOADED TWO TIMES WITH A WHITE MAGAZINE. THE SURGEON COULD NOT FIRE AGAIN SO THEN OPENED A SECOND DEVICE IN ORDER TO FINISH THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOAD PRODUCT #- ECR60W