BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT XPS LASER SYSTEM

    MDR report key: 2852888 · Received November 27, 2012

    Report

    Report Number
    2937094-2012-01207
    Event Type
    Malfunction
    Date Received
    November 27, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 1, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K092735
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE THE LASER SYSTEM DISPLAYED ERRORS INDICATIVE OF A SYSTEM MALFUNCTION. TWO FIBERS WERE TRIED UNSUCCESSFULLY. THE SYSTEM WAS SHUT DOWN AND REBOOTED HOWEVER THE ERRORS PERSISTED. THE SYSTEM WAS NO LONGER ABLE TO BE UTILIZED. THERE WAS NO REPORT OF A PATIENT INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 SURGICAL FIBER(S)