BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT XPS LASER SYSTEM

    MDR report key: 2172200 · Received June 15, 2011

    Report

    Report Number
    2937094-2011-01233
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Date of Event
    May 20, 2011
    Report Date
    May 20, 2011
    Manufacturer
    AMS, INNOVATION CENTER - SILICON VALLEY
    Product Code
    GEX
    PMA / PMN Number
    K092735
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(6) 2011 DURING THE MIDDLE OF THE PROCEDURE, ERROR MESSAGE 102.9 WAS RECEIVED FROM THE LASER SYSTEM. PER THE CUSTOMER, THE LASER SYSTEM WENT INTO SAFETY SHUTDOWN AND CAME BACK ON. ALSO, THE CUSTOMER REPORTED THE PROCEDURE WAS COMPLETED WITH THE LASER SYSTEM. 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