BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT HPS BPH FIBER OPTIC

    MDR report key: 3396047 · Received September 13, 2013

    Report

    Report Number
    2937094-2013-01007
    Event Type
    Malfunction
    Date Received
    September 13, 2013
    Date of Event
    August 1, 2013
    Report Date
    August 19, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING THE SIDE-FIRING SURGICAL FIBER DURING A PROSTATE PROCEDURE, THE "LASER WAS OBSERVED TO FORWARD FIRE AT 150, 227 JOULES." THE PROCEDURE WAS COMPLETED USING A SECOND FIBER. PT OR USER OUTCOME: "NO ADVERSE OUTCOME TO PT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462976 GREENLIGHT HPS BPH FIBER OPTIC POWER SURGICAL LASER INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 10-2090 306H

    Patients

    Seq Age Sex Outcome Treatment
    1