BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 3023825 · Received March 26, 2013

    Report

    Report Number
    2937094-2013-00356
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    February 12, 2013
    Report Date
    March 1, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K128070
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT PROBLEM: THE COMPONENT CODES; FIBER AND CAP ARE ASSOCIATED WITH THE DEVICE CODE BREAK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROSTATE PROCEDURE, THE FIRST FIBER ACTIVATED FIBERLIFE AT 101, 380 JOULES. THE FIBER WAS EXCHANGED. THE FIBER TIP OF THE SECOND FIBER DETACHED AND WAS RETRIEVED. A SECOND FIBER WAS USED TO COMPLETE THE CASE. THIS REPORTS IS FOR THE SECOND FIBER. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123429 GREENLIGHT MOXY FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 0010-2400 250A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other