BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 3061569 · Received April 11, 2013

    Report

    Report Number
    2937094-2013-00440
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 25, 2013
    Report Date
    March 25, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K120870
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROSTATE PROCEDURE, THE SIDE-FIRING FIBER AIMING BEAM FIRES STRAIGHT OUT OF FIBER, PART OF THE BEAM WAS COMING OUT OF THE TIP AND FIBER WAS NOTED AS OVERHEATING AT 569,854 JOULES. A SECOND FIBER WAS USED TO COMPLETE THE CASE. "OUTCOME OK, NO HARM TO PATIENT" REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154728 GREENLIGHT MOXY FIBER OPTIC POWERED SURGICAL LASER INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 0010-2400 302A

    Patients

    Seq Age Sex Outcome Treatment
    1