BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1375923 · Received April 22, 2009

    Report

    Report Number
    1375923
    Event Type
    Malfunction
    Date Received
    April 22, 2009
    Date of Event
    April 9, 2009
    Report Date
    April 22, 2009
    Manufacturer
    NEW STAR LASERS, INC.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE A PATIENT WAS UNDERGOING CYSTO/URETEROSCOPY AND LASER LITHOTRIPSY, ATTEMPTS TO FIRE THE NEW STAR LASER WERE UNSUCCESSFUL, AND AN "ERROR 17" WAS DISPLAYED, WHICH MEANS "LOW LASER OUTPUT". THE SURGEON WAS ABLE TO PROCEED WITH THE PROCEDURE USING AN ELECTRO-LITHOTRIPTOR. THE LASER WAS CALIBRATED AND TESTED BY THE THIRD PARTY COMPANY WHICH IS CONTRACTED TO PROVIDE MAINTENANCE SERVICE ON THE LASER.THE SURGEON NOTED THAT THERE WAS NO ADVERSE IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * LASER, HO:YAG, GENERAL PURPOSE GEX NEW STAR LASERS, INC. NS1500 *

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR