BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX60 ARTICULATING

    MDR report key: 1884086 · Received October 27, 2010

    Report

    Report Number
    1527736-2010-00086
    Event Type
    Malfunction
    Date Received
    October 27, 2010
    Date of Event
    October 4, 2010
    Report Date
    October 4, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS FOUND THAT ONE (B)(4) DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH A FULLY FIRED CARTRIDGE RELOAD LOADED ON THE DEVICE. IN ADDITION 3 RELOADS WERE RECEIVED FOR ANALYSIS. TWO RELOADS WERE RECEIVED FULLY FIRED AND ONE RELOAD WAS RECEIVED UNFIRED. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH THE RETURNED 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 EVENT DESCRIBED COULD NOT BE CONFIRMED AS THE DEVICE PERFORMED WITHOUT ANY DIFFICULTIES NOTED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROUX-EN-Y GASTRIC BYPASS PROCEDURE, ON THE FIRST FIRING WITH A WHITE CARTRIDGE, WHILE TRANSECTING THE JEJUNUM, THE STAPLES DID NOT FORM PROPERLY. THE STAPLE LINE CAME APART. THE STAPLE LINE WAS THEN SEWED MANUALLY. THERE WAS NO IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON*FLEX60 ARTICULATING STAPLE, IMPLANTABLE GDW ETHICON ENDO SURGERY, INC (CINCINNATI) UNK G4TV8W

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4)