BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 3072355 · Received April 18, 2013

    Report

    Report Number
    2937094-2013-00489
    Event Type
    Injury
    Date Received
    April 18, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 10, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K120870
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROSTATE PROCEDURE, THE FIVER CAP HAD DETACHED INSIDE THE PT AT 120, 782 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 TO COMPLETE THE CASE. IT WAS REPORTED "NO HARM TO PT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168270 GREENLIGHT MOXY FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 0010-2400 304B

    Patients

    Seq Age Sex Outcome Treatment
    1 Other