BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT XPS LASER SYSTEM

    MDR report key: 2801550 · Received October 18, 2012

    Report

    Report Number
    2937094-2012-01047
    Event Type
    Malfunction
    Date Received
    October 18, 2012
    Date of Event
    September 21, 2012
    Report Date
    September 21, 2012
    Manufacturer
    AMS
    Product Code
    GEX
    PMA / PMN Number
    K092735
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE THE LASER SYSTEM MALFUNCTIONED SUCH THAT THE COAGULATION MODE COULD NOT BE UTILIZED AS INTENDED. HOWEVER, THE PHYSICIAN WAS ABLE TO CONTINUE TO UTILIZE THE LASER IN AN ALTERNATIVE MODE. THERE WAS NO REPORT OF A PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREENLIGHT XPS LASER SYSTEM POWERED LASER SURGICAL INSTRUMENT GEX AMS 0010-0210 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 SURGICAL FIBER(S)