BEUDAMED
    FDA Adverse Event Other Summary report: N

    GREENLIGHT HPS

    MDR report key: 1582896 · Received January 12, 2010

    Report

    Report Number
    2937094-2010-00001
    Event Type
    Other
    Date Received
    January 12, 2010
    Report Date
    December 13, 2009
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE ENGINEER, CONTRACTED BY AMS, VISITED THE FACILITY AND PERFORMED A QUALITY INSPECTION ON THE LASER. THERE WERE NO PROBLEMS FOUND WITH THE LASER. THE LASER SYSTEM WAS IN MANUFACTURING SPECIFICATION. A PREVENTIVE MAINTENANCE WAS PERFORMED. THE CAUSE OF THE ERROR CODES IS BEING INVESTIGATED. THE FIBER(S) USED IN THIS CASE IS TO BE RETURNED FOR FAILURE ANALYSIS. THE FIBER(S) HAVE NOT YET ARRIVED AT AMS. AMS QUALITY WILL PERFORM A FAILURE ANALYSIS OF THE FIBER(S) AND REPORT RESULTS IN A FOLLOW UP REPORT. THE FIBER LOT # IS 939T. FIBER S/N IS UNK AT THIS TIME. THERE IS NO LOT PROBLEM ASSOCIATED WITH THIS TYPE OF FIBER FAILURE.

    Description of Event or Problem · 1

    THE DOCTOR WAS PERFORMING A GREENLIGHT PVP (PHOTOSELECTIVE VAPORIZATION OF THE PROSTATE) PROCEDURE. FAULT CODES WERE DISPLAYED WITH ONE FIBER AFTER FIVE MINUTES OF USAGE. THEY SWITCHED THE MACHINE OFF AND ON A COUPLE OF TIMES, BUT STILL NO CHANGE. THEY DECIDED TO CONNECT ANOTHER FIBER. AFTER 11 MINUTES OF CONTINUOUS TREATMENT, THERE WAS A FLAME ON THE FIBER AT THE CONNECTOR. THE INFORMATION PROVIDED BY AMS CLINICAL TRAINER: DURING THE PROCEDURE, THE FIBER AT THE CONNECTOR END PRODUCED A FLAME. THIS FLAME PETERED OUT AND THE FIBER DISCONNECTED FROM THE CONNECTOR. THERE WERE NO INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREENLIGHT HPS LASER GEX AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other