BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX45

    MDR report key: 1821680 · Received August 31, 2010

    Report

    Report Number
    3005075853-2010-04976
    Event Type
    Malfunction
    Date Received
    August 31, 2010
    Date of Event
    August 5, 2010
    Report Date
    August 5, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS FOUND THAT ONE EC45A DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH A CARTRIDGE RELOAD LOADED ON THE DEVICE. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST CARTRIDGE RELOAD IN THE ARTICULATED POSITION AND IT 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.

    Description of Event or Problem · 1

    (B)(6) CALLED WHILE MAKING A VISIT TO THIS PATIENT TO LET US KNOW THAT ONE OF HER CURLIN PUMPS HAD A "CLOCK NOT IN ORDER" ALARM GOING OFF. I INSTRUCTED HER TO RETURN THE CURLIN IN EXCHANGE FOR ANOTHER PUMP. (B)(6) WAS NOTIFIED. PUMP NUMBER (B)(4) OR (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING LAPAROSCOPIC NEPHRECTOMY PROCEDURE, ON THE INITIAL FIRING OF THE DEVICE IT MISFIRED AND CAUSED BLEEDING. THE STAPLES WERE NOT COMPLETELY FORMED. THEY USED CLIPS TO CONTROL THE BLEEDING. THERE WAS NO PATIENT IMPACT. (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON*FLEX45 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK G4T94U

    Patients

    Seq Age Sex Outcome Treatment
    1