BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX60 LONG

    MDR report key: 2143202 · Received June 28, 2011

    Report

    Report Number
    3005075853-2011-02669
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 8, 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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS FOUND THAT ONE LONG60A 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A GASTRIC BYPASS PROCEDURE, ON THE INITIAL FIRING WITH A GREEN CARTRIDGE ON THE POUCH, THE STAPLE FORMATION WAS NOT COMPLETE. ON ONE ROW OF EACH SIDE THE STAPLES WERE MALFORMED. THE AREA WAS OVER SEWED. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO IMPACT TO THE PATIENT.

    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 ECR60G