BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENESISPLUS

    MDR report key: 2384826 · Received November 18, 2011

    Report

    Report Number
    2954354-2011-00030
    Event Type
    Malfunction
    Date Received
    November 18, 2011
    Date of Event
    October 25, 2011
    Report Date
    November 18, 2011
    Manufacturer
    CUTERA, INC.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LASER HANDPIECE WAS EVALUATED BY CUTERA FIELD SERVICE ENGINEER. THE CUTERA FSE FOUND A HANDPIECE OPTICAL FAILURE: MID FIBER FAILURE. THE HANDPIECE HAS BEEN RETURNED TO CUTERA FOR FURTHER EVAL.

    Description of Event or Problem · 1

    HANDPIECE OPTICAL MID FIBER FAILURE. IT WAS REPORTED THAT THE LASER LIGHT ESCAPED FROM UMBILICAL CORD FAILURE AND HIT FOOT PEDAL CREATING A SMALL BURN. NO PTS WERE INVOLVED IN THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENESISPLUS GENESISPLUS GEX CUTERA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1