BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 2971450 · Received February 4, 2013

    Report

    Report Number
    2937094-2013-00167
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Date of Event
    December 17, 2012
    Report Date
    January 8, 2013
    Manufacturer
    AMS
    Product Code
    GEX
    PMA / PMN Number
    K120870
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROSTATE PROCEDURE, THE "FIBER CAP DETACHED INSIDE OF PT AND WAS RETRIEVED AT 41,238J". IT WAS "FLUSHED OUT". THE CASE WAS COMPLETED WITH A SECOND FIBER. NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47339 GREENLIGHT MOXY FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMS 0010-2400 229A

    Patients

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