BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT XPS LASER SYSTEM

    MDR report key: 2871742 · Received December 11, 2012

    Report

    Report Number
    2937094-2012-01247
    Event Type
    Malfunction
    Date Received
    December 11, 2012
    Date of Event
    October 12, 2010
    Report Date
    November 12, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K092735
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, THE DISPLAY SCREEN WENT BLANK. DETAILS REGARDING HOW THE PHYSICIAN PROCEEDED WITH THE PROCEDURE HAVE NOT BEEN AVAILABLE. NO REPORT OF INJURY TO THE PT AND/OR USER.

    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)