BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 2970090 · Received February 15, 2013

    Report

    Report Number
    2937094-2013-00228
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    December 7, 2012
    Report Date
    February 1, 2013
    Manufacturer
    AMS INNOVATIVE CENTER-SAN JOSE
    Product Code
    GEX
    PMA / PMN Number
    K120870
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE CODE (NO CODE AVAILABLE) REFERS TO FORWARD-FIRING OF THE SIDE-FIRING SURGICAL FIBER; A CODE REQUEST HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SIDE-FIRING FIBER WAS NOTICED TO HAVE COMMENCED FORWARD FIRING AT 311, 382 JOULES DURING A PROSTATE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A SECOND FIBER. NO INJURY TO PATIENT REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68812 GREENLIGHT MOXY FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMS INNOVATIVE CENTER-SAN JOSE 0010-2400 240A

    Patients

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