BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT HPS BPH FIBER OPTIC

    MDR report key: 3931203 · Received July 10, 2014

    Report

    Report Number
    3931203
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Date of Event
    October 9, 2013
    Report Date
    July 10, 2014
    Manufacturer
    AERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SPARK SEEN AND LASER FIBER APPEARED BURNT AT TIP. NOTED CLEAR COATING MISSING. ALL PARTS RETRIEVED. SETTINGS ON LASER VAPOR 80, COAG 20. NO HARM TO PATIENT OR STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405339 GREENLIGHT HPS BPH FIBER OPTIC LASER FIBER GEX AERICAN MEDICAL SYSTEMS 10-2090 10-2090-305K

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR CYSTOSCOPE