BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 2842007 · Received November 14, 2012

    Report

    Report Number
    2937094-2012-01194
    Event Type
    Injury
    Date Received
    November 14, 2012
    Date of Event
    October 16, 2012
    Report Date
    October 23, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K100746
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FIBER HAD DETACHED 3/4 OF AN INCH FROM THE TIP INSIDE THE PT AT 78,336 JOULES INTO THE CASE. THE PHYSICIAN WAS ABLE TO RETRIEVE THE FIBER FRAGMENTS, METHOD OF REMOVAL IS UNK. THERE WAS NO INDICATION OR REPORT OF ANY PART OF THE DEVICE REMAINING INSIDE THE PT. THE PROCEDURE WAS COMPLETED WITH ANOTHER FIBER. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREENLIGHT MOXY FIBER OPTIC POWERED LASER SURGICLA INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 0010-2400 227A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention GREENLIGHT XPS LASER SYSTEM| ACCESSORIES