BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT HPS

    MDR report key: 1807069 · Received August 12, 2010

    Report

    Report Number
    1807069
    Event Type
    Malfunction
    Date Received
    August 12, 2010
    Date of Event
    August 6, 2010
    Report Date
    August 12, 2010
    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

    STAFF BRUSHED AGAINST GREEN LIGHT LASER MACHINE AND THE MACHINE ALARMED AND SAID FIBER EXPIRED, ANOTHER FIBER FROM THE SAME COMPANY WAS USED AND THE CASE COMPLETED WITHOUT FURTHER OCCURRENCE. LASER FIBER BEING RETURNED TO COMPANY AMERICAN MEDICAL SYSTEMS (AMS) GREENLIGHT HPS, BPH FIBER OPTIC, # 10-2090, LOT 10-2090-015T, EXP DATE 2012-04.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREENLIGHT HPS LASER FIBER GEX AMERICAN MEDICAL SYSTEMS INC. 10-2090 10-2090-015T

    Patients

    Seq Age Sex Outcome Treatment
    1 *