BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GREENLIGHT XPS MOXY FIBER OPTIC

    MDR report key: 3110986 · Received May 9, 2013

    Report

    Report Number
    2937094-2013-00555
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 19, 2013
    Report Date
    April 25, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K120870
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REFERENCE MFR. REPORT # 2937094-2013-00553.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROSTATE PROCEDURE BOTH THE METAL AND GLASS CAP OF THE FIRST FIBER DETACHED AT 175,400 JOULES INSIDE OF THE PT AND WERE FLUSHED OUT WITHOUT ISSUE. A SECOND FIBER WAS USED. BOTH THE METAL AND GLASS CAP OF THE SECOND FIBER DETACHED AT 209,718 JOULES INSIDE OF THE PT AND WERE FLUSHED OUT WITHOUT ISSUE. THE CASE WAS COMPLETED WITH A THIRD FIBER. NO PT OUTCOME PROVIDED. THIS REPORT IS FOR THE SECOND FIBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202551 GREENLIGHT XPS MOXY FIBER OPTIC POWERED SURGICAL LASER INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 0010-2400 233A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other