BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT XPS LASER SYSTEM

    MDR report key: 2227550 · Received August 15, 2011

    Report

    Report Number
    2937094-2011-01708
    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
    K092735
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY AN AMERICAN MEDICAL SYSTEMS SALES REPRESENTATIVE ON (B)(6) 2011 THAT DURING THE PROCEDURE ERROR MESSAGE CODE 130 POWER WATCHDOG TIMEOUT POWER CONTROLLER HAS NOT RECEIVED PHOTODIODE DATA FROM RCB WITHIN TIMEOUT PERIOD WAS RECEIVED. PER THE AMERICAN MEDICAL SYSTEMS SALES REPRESENTATIVE, THE CUSTOMER REPORTED TO HER THAT THE ERROR MESSAGE CODE 130 COMES UP NOW EVERY SINGLE CASE, TOWARD THE END OF THE CASES. PER THE CUSTOMER, THE CASES WERE ABLE TO BE CONTINUED AND COMPLETED WITH NO HARM TO THE PT BY SHUTTING DOWN AND REBOOTING THE LASER SYSTEM TO CLEAR THE ERROR MESSAGE CODE. ADDITIONAL INFO PROVIDED BY THE CUSTOMER STATED ERROR MESSAGE CODE 130 BECAME A REOCCURRING ERROR WITH THIS LASER SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREENLIGHT XPS LASER SYSTEM LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY 0010-0210 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other