BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 2912804 · Received January 8, 2013

    Report

    Report Number
    2937094-2013-00023
    Event Type
    Injury
    Date Received
    January 8, 2013
    Date of Event
    December 10, 2012
    Report Date
    December 13, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K100746
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROSTATE PROCEDURE, THE FIBER TIP (METAL CAP) DETACHED AND FELL INTO THE PROSTATE. IT WAS REMOVED WITH PINCERS. SURGERY HAD TO BE POSITIONED AS THERE WERE NO MORE FIBERS IN STOCK. CURRENT STATUS OF PT WAS REPORTED AS "PERFECT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10263 GREENLIGHT MOXY FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 0010-2400 148A

    Patients

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