BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 2960279 · Received February 8, 2013

    Report

    Report Number
    2937094-2013-00165
    Event Type
    Injury
    Date Received
    February 8, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 16, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K100746
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROSTATE PROCEDURE, THE FIBER TIP HAS DETACHED INSIDE THE PT AT 28,482 JOULES. THE FIBER CAP WAS RETRIEVED, METHOD OF REMOVAL IS UNK. THERE WAS NO INDICATION OR REPORT OF ANY PART OF THE DEVICE REMAINING INSIDE THE PT. A SECOND FIBER WAS USED AND HAD FIBER TIP DAMAGE AND STOPPED FIRING AT THE TIP AT 79,276 JOULES. THE PHYSICIAN REVERTED TO TURP TO COMPLETE THE CASE. IT WAS REPORTED "NO INJURY TO THE PT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54249 GREENLIGHT MOXY FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 0010-2400 245B

    Patients

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