BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT XPS LASER SYSTEM

    MDR report key: 2037626 · Received February 16, 2011

    Report

    Report Number
    2937094-2011-00171
    Event Type
    Malfunction
    Date Received
    February 16, 2011
    Date of Event
    February 2, 2011
    Report Date
    February 2, 2011
    Manufacturer
    AMS, INNOVATION CENTER-SILICON VALLEY
    Product Code
    GEX
    PMA / PMN Number
    K092735
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER ON (B)(6) 2011, THAT DURING THE MIDDLE OF THE PROCEDURE, THE LASER SYSTEM SHUT OFF. PER THE CUSTOMER, THE SCREEN WENT BLANK AND THE LASER STOPPED FIRING. NO PT INJURY WAS REPORTED. PER AMERICAN MEDICAL SYSTEMS TECHNICAL SUPPORT, ADVISED CUSTOMER TO SHUT LASER OFF/ON BY CIRCUIT BREAKER. PER THE CUSTOMER, THIS WAS ALREADY DONE 3 TIMES AND THE LASER STILL DID NOT TURN ON.

    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