BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 3060180 · Received April 11, 2013

    Report

    Report Number
    2937094-2013-00456
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    February 13, 2013
    Report Date
    April 8, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K120870
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) REFERS TO FORWARD-FIRING OF THE SIDE-FIRING SURGICAL FIBER; A CODE REQUEST HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROSTATE PROCEDURE, THE SIDE-FIRING FIBER WAS OBSERVED TO "FIRE STRAIGHT". THE PROCEDURE WAS COMPLETED WITH TURP. "NO INJURY TO PATIENT" REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155556 GREENLIGHT MOXY FIBER OPTIC POWERED SURGICAL LASER INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 0010-2400 248A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other