BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 2971435 · Received February 4, 2013

    Report

    Report Number
    2937094-2013-00156
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Date of Event
    January 4, 2013
    Report Date
    January 8, 2013
    Manufacturer
    AMS
    Product Code
    GEX
    PMA / PMN Number
    K100746
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPONENT CODES FIBER AND CAP ARE ASSOCIATED WITH THE DEVICE CODE BREAK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FIBER CAP DETACHED DURING THE PROCEDURE. A SECOND FIBER WAS USED TO COMPLETE THE CASE. NO INJURY TO THE PT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47336 GREENLIGHT MOXY FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMS 0010-2400 241A

    Patients

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