BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 3983027 · Received August 6, 2014

    Report

    Report Number
    2937094-2014-00685
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    July 14, 2014
    Report Date
    July 14, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)
    Product Code
    GEX
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING THE SURGICAL FIBER DURING A PROSTATE PROCEDURE, THE MOXY FIBER FRACTURED OUTSIDE THE LASER CYSTOSCOPE SHEATH. A FLASH OF LIGHT WAS OBSERVED NEAR THE PHYSICIANS HAND, JUST OUTSIDE THE FIBER ENTRY PORT INTO THE CYSTOSCOPE SHEATH. NO INJURY WAS REPORTED TO THE PHYSICIAN OR ANYONE ON THE OPERATING THEATER. THE PROCEDURE WAS COMPLETED USING A SECOND SURGICAL FIBER. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462002 GREENLIGHT MOXY FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) 0010-2400

    Patients

    Seq Age Sex Outcome Treatment
    1