BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT HPS LASER SYSTEM

    MDR report key: 2227547 · Received August 15, 2011

    Report

    Report Number
    2937094-2011-01707
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    July 20, 2011
    Report Date
    July 20, 2011
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2011, THE AMERICAN MEDICAL SYSTEMS SALES REPRESENTATIVE CONFERENCED IN WITH AMERICAN MEDICAL SYSTEMS TECHNICAL SUPPORT FOR HELP WITH TROUBLESHOOTING THE "WHITE SCREEN" ISSUE. AMERICAN MEDICAL SYSTEMS TECHNICAL SUPPORT ADVISED TO SWITCH OFF THE CIRCUIT BREAKER AND UNPLUG THE CONSOLE FROM THE EXTERNAL POWER AND CHECK THE FUSES ON THE POWER DISTRIBUTION BOARD. PER AMERICAN MEDICAL SYSTEMS SALES REPRESENTATIVE, THE FUSE WAS FOUND BURNED AND WAS REPLACED. THE CONSOLE WAS POWERED BACK UP AND THE DISPLAY SCREEN DISPLAYED CORRECTLY. NO PRODUCT WILL BE RETURNED TO AMERICAN MEDICAL SYSTEMS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY AN AMERICAN MEDICAL SYSTEMS SALES REPRESENTATIVE ON (B)(6) 2011 THAT WHILE THE PT WAS ON THE TABLE, THE LASER SYSTEM HAD A WHITE SCREEN. THE AMERICAN MEDICAL SYSTEMS SALES REPRESENTATIVE WAS CONFERENCED IN WITH AMERICAN MEDICAL SYSTEMS TECHNICAL SUPPORT WHO REQUESTED TO HAVE THE FUSE CHECKED. PER THE AMERICAN MEDICAL SYSTEMS SALES REPRESENTATIVE, THE FUSE WAS CHECKED AND THE LASER SYSTEM WAS POWERED ON. ONCE THE LASER SYSTEM WAS POWERED ON, THE PROCEDURE WAS CONTINUED AND COMPLETED WITH NO PROBLEMS. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREENLIGHT HPS LASER SYSTEM LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY 0010-0070 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other