BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSA EXCEL 36KHZ

    MDR report key: 3770261 · Received November 20, 2013

    Report

    Report Number
    3006697299-2013-00077
    Event Type
    Malfunction
    Date Received
    November 20, 2013
    Report Date
    November 20, 2013
    Manufacturer
    INTEGRA NEUROSCIENCES, LTD
    Product Code
    LBK
    PMA / PMN Number
    K981262
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 INFORMATION.

    Description of Event or Problem · 1

    STRAIGHT HANDPIECE WAS NOT COOLING OFF AND WATER DRIPS. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604487 CUSA EXCEL 36KHZ ULTROSONIC SURGICAL PRODUCTS LBK INTEGRA NEUROSCIENCES, LTD

    Patients

    Seq Age Sex Outcome Treatment
    1