BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT HPS BPH FIBER OPTIC

    MDR report key: 2980133 · Received February 21, 2013

    Report

    Report Number
    2937094-2013-00266
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 24, 2013
    Report Date
    February 5, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SIDE-FIRING FIBER WAS NOTICED TO HAVE COMMENCED FORWARD FIRING AT 96,189 JOULES DURING A PROSTATE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A SECOND FIBER. NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77069 GREENLIGHT HPS BPH FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 0010-2090 242H

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCESSORIES| GREENLIGHT HPS LASER SYSTEM