BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGLED DELIVERY DEVICE, GREENLIGHT XPS

    MDR report key: 2438501 · Received January 13, 2012

    Report

    Report Number
    2937094-2012-00020
    Event Type
    Malfunction
    Date Received
    January 13, 2012
    Date of Event
    December 15, 2011
    Report Date
    December 15, 2011
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    GEX
    PMA / PMN Number
    K100746
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE AIMING BEAM FIRED STRAIGHT. THE JOULE COUNT AT THE TIME THE FIBER ISSUE WAS OBSERVED WAS NOT PROVIDED. THE CASE WAS COMPLETED WITH ANOTHER FIBER. NO PT INJURY WAS REPORTED. ADD'L DETAILS WERE REQUESTED BY THE MFR AND HAVE NOT BEEN OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGLED DELIVERY DEVICE, GREENLIGHT XPS SURGICAL FIBER GEX AMERICAN MEDICAL SYSTEMS, INC. 0010-2400 139A

    Patients

    Seq Age Sex Outcome Treatment
    1 & ACCESSORIES| GREENLIGHT XPS SURGICAL LASER SYS