BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 3040485 · Received April 3, 2013

    Report

    Report Number
    2937094-2013-00413
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 26, 2013
    Report Date
    March 28, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K120870
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) REFERS TO FORWARD-FIRING OF THE SIDE-FIRING SURGICAL FIBER; A CODE REQUEST HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SIDE-FIRING FIBER WAS NOTICED TO HAVE COMMENCED FORWARD FIRING AT 5000 JOULES INTO THE CASE DURING A PROSTATE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A SECOND FIBER. IT WAS REPORTED NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136257 GREENLIGHT MOXY FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 0010-2400 302A

    Patients

    Seq Age Sex Outcome Treatment
    1