BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT XPS LASER SYSTEM

    MDR report key: 2090755 · Received April 26, 2011

    Report

    Report Number
    2937094-2011-00838
    Event Type
    Malfunction
    Date Received
    April 26, 2011
    Date of Event
    March 30, 2011
    Report Date
    April 8, 2011
    Manufacturer
    AMS, INNOVATION CENTER - SILICON VALLEY
    Product Code
    GEX
    PMA / PMN Number
    K092735
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(6) 2011 DURING THE MIDDLE OF THE PROCEDURE ERROR CODE 302.2 FOLLOWED BY ERROR CODE 850 AND THEN FOLLOWED BY ERROR CODE 202.11 WERE RECEIVED FROM THE LASER SYSTEM. ALSO, IT WAS REPORTED THAT THE CLEAR PROBLEMS BUTTON WAS PRESSED. THE LASER SYSTEM ADVISED TO PRESS THIS BUTTON TO CONTINUE. THE LASER SYSTEM SCREEN CAME UP WITH 5:35 BUT IT NEVER WENT LOWER THAN 5:19 BEFORE THE ERROR CODES REAPPEARED. ERROR CODE 850 WAS THE FIRST CODE TO APPEAR FOLLOWED BY THE OTHER ERROR CODES. THE LASER SYSTEM WENT INTO SAFETY SHUT DOWN. THE LASER SYSTEM WAS RE-BOOTED AND THE ERROR CODES WERE NOT RECEIVED. THE PROCEDURE WAS COMPLETED. NO PT INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other