BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSA NXT CONSOLE (115-230V)

    MDR report key: 2600493 · Received June 1, 2012

    Report

    Report Number
    3006697299-2012-00025
    Event Type
    Malfunction
    Date Received
    June 1, 2012
    Report Date
    June 1, 2012
    Manufacturer
    INTEGRA LIFESCIENCES (IRELAND) LIMITED
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A CUSA NXT THAT WAS BEING USED DURING A PROCEDURE SEEMED TO BE CAUSING 24 KHZ HAND PIECES FROM THE SAME FACILITY (CROSS REFERENCE WITH MFR REPORT # 8010219-2012-00014) TO HEAT UP TO AN EXCESSIVE TEMPERATURE AND THE POWER WAS NOT CONSISTENT. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1