BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 3130065 · Received May 20, 2013

    Report

    Report Number
    2937094-2013-00602
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    April 29, 2013
    Report Date
    May 5, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K120870
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) REFERS TO FORWARD-FIRING OF THE SIDE-FIRING SURGICAL FIBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROSTATE PROCEDURE, THE SIDE-FIRING FIBER WAS OBSERVED TO BE "FORWARD FIRING AND/OR NOTED TO HAVE FIBER DAMAGE AT THE TIP." A SECOND DEGREE FIBER WAS USED TO COMPLETE THE CASE. "NO DAMAGES TO THE PATIENT" REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223288 GREENLIGHT MOXY FIBER OPTIC POWERED SURGICAL LASER INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 0010-2400 243A

    Patients

    Seq Age Sex Outcome Treatment
    1