BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCEL CONSOLE WITH FOOTSWITCH EACH 1

    MDR report key: 1873526 · Received September 22, 2010

    Report

    Report Number
    3006697299-2010-00010
    Event Type
    Malfunction
    Date Received
    September 22, 2010
    Report Date
    September 22, 2010
    Manufacturer
    INTEGRA LIFESCIENCES (IRELAND) LTD
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE REPORTED INFORMATION, THE FINDINGS WERE AS FOLLOWS: CUSTOMER ERROR IN SETTING UP THE CONSOLE. THE ASPIRATION AND IRRIGATION TUBING HAVE DIFFERENT DIAMETERS AND ARE ALSO COLOR CODED. THE ONLY WAY THAT PT BODY FLUID COULD BE INPUTTED TO THE SUCTION MOTOR WAS FOR THE TUBING TO BE CONNECTED TO THE WRONG INPUT, EITHER BY FORCE OR VIA AN ADAPTER. THE INSTRUCTIONS FOR USE (IFU) CLEARLY STATES HOW THE CONSOLE SHOULD BE SET UP. THE INCIDENT WAS USER ERROR AND NOT PRODUCT FAILURE. INTERGRA CONSIDERS THIS COMPLAINT INVESTIGATION CLOSED. FUTURE INCIDENTS OF THIS NATURE WILL BE DOCUMENTED FOR RECURRENCE AND TRENDING PURPOSES.

    Description of Event or Problem · 1

    ON AN UNK DATE, IT WAS REPORTED THAT CUSA EXCEL FAILED. THE SURGICAL FLUID WASTE GOT SUCKED INTO THE SUCTION MOTOR, WHICH CREATED A SHORT CIRCUIT IN THE CONTROL BOARD AND IRRIGATION MOTOR CONTROLLER BOARD. THE SUCTION MOTOR, SUCTION CONTROLLER BOARD, IRRIGATION MOTOR AND IT'S CONTROLLER BOARDS WERE FOUND TO BE FAULTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXCEL CONSOLE WITH FOOTSWITCH EACH 1 ULTRASONIC SURGICAL PRODUCTS LFL INTEGRA LIFESCIENCES (IRELAND) LTD

    Patients

    Seq Age Sex Outcome Treatment
    1