BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GREENLIGHT XPS MOXY FIBER OPTIC

    MDR report key: 3132951 · Received May 16, 2013

    Report

    Report Number
    2937094-2013-00587
    Event Type
    Injury
    Date Received
    May 16, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 7, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K120870
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROSTATE PROCEDURE BOTH METAL AND GLASS CAPS DETACHED FROM THE FIBER AT 258,166 JOULES WHILE INSIDE OF THE PATIENT. SURGICAL PLIERS WERE USED TO REMOVE THE CAP. THE CASE WAS COMPLETED WITH A SECOND FIBER. PATIENT OR USER OUTCOME: NO DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218444 GREENLIGHT XPS MOXY FIBER OPTIC POWERED SURGICAL LASER INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 0010-2400 251A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other