BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 4863503 · Received June 23, 2015

    Report

    Report Number
    2937094-2015-00640
    Event Type
    Malfunction
    Date Received
    June 23, 2015
    Date of Event
    June 5, 2015
    Report Date
    June 5, 2015
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)
    Product Code
    GEX
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BPH PROSTATE PROCEDURE AT 27,000 JOULES AT 80W AND 120W THE FIBER WAS LACKING POWER. IT WAS NOTED THAT THE TIP OF THE FIBER HAD BROKEN OFF INSIDE THE PATIENT. THE TIP WAS RETRIEVED AND THE FIBER EXCHANGED. AT ABOUT 200,000 JOULES AT 140W THE SECOND FIBER WAS ALSO LOSING POWER AND THE TIP OF FIBER WAS CRACKING AND BREAKING AND FINISHED AT 286,000 JOULES. THE CASE WAS COMPLETED BY AN ALTERNATIVE PROCEDURE CALLED "THE BUTTON". PATIENT OUTCOME: "OK" WAS REPORTED. THIS REPORT IS FOR THE SECOND FIBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405306 GREENLIGHT MOXY FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) 0010-2400 501A

    Patients

    Seq Age Sex Outcome Treatment
    1