BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREEN LIGHT PV

    MDR report key: 1242031 · Received November 17, 2008

    Report

    Report Number
    1242031
    Event Type
    Malfunction
    Date Received
    November 17, 2008
    Date of Event
    October 20, 2008
    Report Date
    November 17, 2008
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US

    Narratives

    Description of Event or Problem · 1

    SURGEON STATED THE TIP HAD PEELED OFF THE LASER FIBER (IT WAS NOT IN THE PATIENT). THE KEY ON THE LASER WAS INADVERTENTLY HIT WHILE OPENING THE 2ND FIBER AND TURNED TO THE OFF POSITION. THE MACHINE REBOOTED 12/14 SELF TESTS THEN DISPLAYED PROBLEM 122. THE MACHINE WAS TURNED OFF AND REBOOTED SUCCESSFULLY. CLINICAL ENGINEERING WAS CALLED AND THE PROCEDURE WAS COMPLETED WITH THE SECOND FIBER WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREEN LIGHT PV FIBER, LASER GEX AMERICAN MEDICAL SYSTEMS, INC. 10-2079-8182 *

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR