BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 2970101 · Received February 15, 2013

    Report

    Report Number
    2937094-2013-00227
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    December 17, 2012
    Report Date
    January 23, 2013
    Manufacturer
    AMS INNOVATIVE CENTER-SAN JOSE
    Product Code
    GEX
    PMA / PMN Number
    K120870
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 DURING A PROSTATE PROCEDURE. A SECOND FIBER WAS USED UP TO 250,000 JOULES AND THEN REPLACED WITH A THIRD FIBER THAT WAS USED TO COMPLETE THE PROCEDURE. THIS REPORT IS FOR THE FIRST FIBER. "NO DAMAGE TO THE PATIENT'' REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68908 GREENLIGHT MOXY FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMS INNOVATIVE CENTER-SAN JOSE 0010-2400 239A

    Patients

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