BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 3042070 · Received April 1, 2013

    Report

    Report Number
    2937094-2013-00396
    Event Type
    Injury
    Date Received
    April 1, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 19, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K120870
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FIBER AND CAP ARE ASSOCIATED WITH BROKE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROSTATE PROCEDURE, THE FIBER DECREASED IN FIBER EFFICIENCY AND THE FIBER CAP DETACHED INSIDE THE PT AT 141,353 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. THE PROCEDURE WAS COMPLETED WITH A SECOND FIBER. "NO HARM TO THE PT" WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132623 GREENLIGHT MOXY FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 0010-2400 245A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other