BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT HPS BPH FIBER OPTIC

    MDR report key: 2871740 · Received December 11, 2012

    Report

    Report Number
    2937094-2012-01279
    Event Type
    Malfunction
    Date Received
    December 11, 2012
    Date of Event
    June 6, 2012
    Report Date
    October 4, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROSPECT PROCEDURE, THE FIBER TIP BURNED OUT AT 42,000 JOULES. A SECOND FIBER WAS USED AND THE CAP DETACHED AT 30,326 JOULES INTO THE PROCEDURE. THIS FIBER WAS USED TO COMPLETE THE CASE. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREENLIGHT HPS BPH FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 0010-2090 203H

    Patients

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