BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON 45 ENDOPATH STAPLER

    MDR report key: 1893439 · Received November 8, 2010

    Report

    Report Number
    3005075853-2010-06373
    Event Type
    Malfunction
    Date Received
    November 8, 2010
    Date of Event
    September 30, 2010
    Report Date
    October 13, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS SHOWED THAT ONE EC45 DEVICE WAS RETURNED WITH NO VISUAL NON-CONFORMANCES AND WITH A BLUE FULLY FIRED RELOAD LOADED ON THE DEVICE. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD AND IT ACHIEVED A COMPLETE 3-STROKES FIRE WITHOUT ANY DIFFICULTIES NOTED. THE DEVICE FIRED, CUT AND FORMED ALL THE STAPLES AS INTENDED. THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORM SHAPE. THE EVENT COULD NOT BE CONFIRMED AS THE DEVICE OPENED AND CLOSED AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER CHECKED THE CELL-DYN ANALYZER PER FA25AUG2010 LETTER AND REPORTED AN INCORRECT POWER SUPPLY FUSE INSTALLED IN THE ANALYZER. THE CORRECT FUSE WAS ORDERED WITH NO IMPACT TO PATIENT RESULTS, PATIENT MANAGEMENT OR USER SAFETY.

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS PAIN AND LIMITED FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON 45 ENDOPATH STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK G4RF1W

    Patients

    Seq Age Sex Outcome Treatment
    1