BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY

    MDR report key: 2253536 · Received September 6, 2011

    Report

    Report Number
    2937094-2011-01798
    Event Type
    Malfunction
    Date Received
    September 6, 2011
    Date of Event
    July 11, 2011
    Report Date
    August 8, 2011
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    GEX
    PMA / PMN Number
    K100746
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A VOLUNTARY REPORT INDICATED ON (B)(6) 2011 THAT THE USER EXPERIENCED A "SHORTING OUT" DURING A BENIGN PROSTATIC HYPERTROPHY (BPH) LASER PROCEDURE. PER THE CUSTOMER, THIS PRODUCT IS A NEW FIBER MODEL USED IN LASER PROCEDURES. IT WAS NOTED THAT THE FIBER WAS BREAKING AT THE DISTAL FIBER TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREENLIGHT MOXY SURGICAL FIBER GEX AMERICAN MEDICAL SYSTEMS, INC. NA 116A

    Patients

    Seq Age Sex Outcome Treatment
    1