BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSA NXT CONSOLE (115-230V)

    MDR report key: 2180792 · Received July 7, 2011

    Report

    Report Number
    3006697299-2011-00026
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Report Date
    July 7, 2011
    Manufacturer
    INTEGRA, TULLAMORE
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    THIS IS THE SECOND REPORT OF AN INCIDENT INVOLVING THE SAME UNIT AT THE SAME FACILITY. CROSS REFERENCE WITH MFR. #3006697299-2011-00015. (B)(4). A CUSA NXT CONSOLE (B)(4) FAILED DURING A PROCEDURE AND WAS DESCRIBED AS FOLLOWS; THIS INCIDENT OCCURRED IN THE OPERATING ROOM (DATE OF EVENT UNK) WHILE THE PT WAS ANESTHETIZED FOR A CRANIOTOMY FOR TUMOR REMOVAL. THE UNIT WAS TURNED ON AND THE COOLING WATER ALERT ALARMED. AS A RESULT, THE TUMOR WAS REMOVED MANUALLY. THE UNIT NEVER CONTACTED THE PT, THERE WAS NO INJURY AND THERE WAS NO DELAY IN SURGERY. THE SURGERY WAS SUCCESSFUL WITHOUT THE USE OF THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSA NXT CONSOLE (115-230V) ULTRASONIC SURGICAL PRODUCTS LFL INTEGRA, TULLAMORE

    Patients

    Seq Age Sex Outcome Treatment
    1