BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 3883274 · Received June 19, 2014

    Report

    Report Number
    2937094-2014-00521
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 11, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)
    Product Code
    GEX
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROSTATE PROCEDURE "FIBER CAP DETACHED @ 87933 JOULES 14:01 MINUTES OF LASING TIME", IT WAS NOTED THAT THE FIBER CAP DETACHED INSIDE THE PATIENT AND THE FIBER CAP WAS RETRIEVED ¿ CASE WAS COMPLETED WITH A SECOND FIBER, NO NEGATIVE PATIENT OUTCOME¿ REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361560 GREENLIGHT MOXY FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) 0010-2400 351A

    Patients

    Seq Age Sex Outcome Treatment
    1