BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 2883075 · Received December 18, 2012

    Report

    Report Number
    2937094-2012-01306
    Event Type
    Malfunction
    Date Received
    December 18, 2012
    Date of Event
    November 8, 2012
    Report Date
    November 20, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K100746
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A FIBER CAP DETACHMENT DURING A PROSTATE PROCEDURE COULD RESULT IN A FORWARD FIRING CONDITION OF THE SIDE-FIRING SURGICAL FIBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT 69,488 JOULES OF USE, THE SURGICAL FIBERS CAP DETACHED INSIDE OF THE PT DURING A PROSTATE PROCEDURE. THE FIBER CAP WAS REPORTED TO HAVE BEEN RETRIEVED FROM THE PT AND THE CASE COMPLETED BY TURP. THERE WAS NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREENLIGHT MOXY FIBER OPTIC POWERED SURGICAL LASER INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 10-2400 235A

    Patients

    Seq Age Sex Outcome Treatment
    1 GREENLIGHT XPS LASER SYSTEM| ACCESSORIES