BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 3023847 · Received March 26, 2013

    Report

    Report Number
    2937094-2013-00365
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    January 25, 2013
    Report Date
    March 8, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K120870
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROSTRATE PROCEDURE, FIBER TIP BROKE AT 92,705 JOULES. THE PHYSICIAN PERFORMED A TURP TO COMPLETE THE CASE. "NO HARM TO THE PT" REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124529 GREENLIGHT MOXY FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 0010-2400 245V

    Patients

    Seq Age Sex Outcome Treatment
    1 Other