BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGLED DELIVERY DEVICE, GREENLIGHT XPS

    MDR report key: 2432892 · Received January 11, 2012

    Report

    Report Number
    2937094-2012-00011
    Event Type
    Malfunction
    Date Received
    January 11, 2012
    Date of Event
    December 12, 2011
    Report Date
    December 12, 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 FIBER WAS OBSERVED TO BE FORWARD FIRING AT 166106 JOULES. A SECOND FIBER WAS USED TO COMPLETE THE CASE. 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 140A

    Patients

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