BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT HPS BPH FIBER OPTIC

    MDR report key: 3040491 · Received April 3, 2013

    Report

    Report Number
    2937094-2013-00402
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 18, 2013
    Report Date
    March 21, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IN SECTION F10 EVENT PROBLEM CODES, THE COMPONENT CODE FIBER AND CAP ARE ASSOCIATED WITH THE DEVICE CODE BREAK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROSTATE PROCEDURE, FIBER CAP HAD DETACHED AT 7000 JOULES. THE PROCEDURE WAS COMPLETED WITH A SECOND FIBER. NO ADDITIONAL INFORMATION WAS AVAILABLE. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136191 GREENLIGHT HPS BPH FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 0010-2090 244H

    Patients

    Seq Age Sex Outcome Treatment
    1