BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT XPS LASER SYSTEM

    MDR report key: 1981526 · Received January 31, 2011

    Report

    Report Number
    2937094-2011-00003
    Event Type
    Malfunction
    Date Received
    January 31, 2011
    Date of Event
    January 4, 2011
    Report Date
    January 4, 2011
    Manufacturer
    AMS 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 THE CUSTOMER ON (B)(6) 2011 THAT DURING THE PROCEDURE, THE CUSTOMER EXPERIENCED ERROR CODES 652, 602.11, 202.11 FROM THE LASER SYSTEM. ALSO, THE CUSTOMER RECEIVED A MESSAGE TO CLICK TO CLEAR THE ERROR AND THEN THE CUSTOMER RECEIVED AN ERROR CODE 330. PER THE CUSTOMER, THE KEY WAS TURNED OFF, THE BREAKER WAS SHUT DOWN AND THE SAME ERROR CODES WERE STILL RECEIVED FROM THE LASER SYSTEM. THE CUSTOMER WAS CONFERENCED IN WITH TECHNICAL SUPPORT AND WAS ADVISED TO ADD WATER TO THE LASER SYSTEM. THE CUSTOMER ADDED WATER TO THE LASER SYSTEM BUT STILL RECEIVED THE SAME ERROR CODES. THE LASER SYSTEM WAS REPAIRED.

    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