BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEW STAR LASER

    MDR report key: 882058 · Received June 12, 2007

    Report

    Report Number
    882058
    Event Type
    Malfunction
    Date Received
    June 12, 2007
    Date of Event
    May 7, 2007
    Report Date
    June 12, 2007
    Manufacturer
    NEW STAR LASERS, INC.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US

    Narratives

    Description of Event or Problem · 1

    LASER TURNED ITSELF OFF DURING THE MIDDLE OF A LITHOTRIPSY AND WOULD NOT TURN BACK ON. LASER WAS TAKEN AWAY FROM THE FIELD. AN ELECTROHYDRAULIC LITHOTRIPTOR WAS USED IN ITS PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEW STAR LASER LASER GEX NEW STAR LASERS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR