BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGREENLIGHT MOXY FIBER OPTIC

    MDR report key: 2850534 · Received November 15, 2012

    Report

    Report Number
    2937094-2012-01192
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    September 7, 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
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FIBER CAP DETACHED INSIDE OF THE PT AT 34340 JOULES INTO THE CASE. THE CAP WAS RETRIEVED WITH THE USE OF A GRASPER FROM INSIDE OF THE PT. THERE WAS NO INDICATION OR REPORT OF ANY PART OF THE DEVICE REMAINING INSIDE THE PT. IT WAS REPORTED THAT THE CASE WAS COMPLETED WITH THE USER OF A SECOND FIBER. THERE WAS NO REPORT OF INJURY TO THE PT AND/OR THE USER AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AGREENLIGHT MOXY FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 0010-2400 218A

    Patients

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