BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSA EXCEL 36KHZ CEM NOSECONE

    MDR report key: 3884316 · Received May 26, 2014

    Report

    Report Number
    3006697299-2014-00039
    Event Type
    Malfunction
    Date Received
    May 26, 2014
    Report Date
    April 25, 2014
    Manufacturer
    INTEGRA LIFESCIENCES IRELAND LIMITED
    Product Code
    LFL
    PMA / PMN Number
    K981262
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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

    PROBLEM OF DIATHERMY: DIATHERMY ACTIVATED EVEN WHEN THE BUTTON IS NOT PUSHED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309939 CUSA EXCEL 36KHZ CEM NOSECONE ULTRASONIC SURGICAL PRODUCT LFL INTEGRA LIFESCIENCES IRELAND LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1