BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 2940971 · Received January 29, 2013

    Report

    Report Number
    2937094-2013-00158
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Date of Event
    November 7, 2012
    Report Date
    November 7, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K100746
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPONENT CODES FIBER AND CAP REFER TO THE RESULTS CODE THERMAL PROBLEM. FIBER ANALYSIS: THE FIBER'S METAL AND GLASS CAPS WERE FOUND TO BE DETACHED; THE FIBER BROKEN PROXIMAL TO THE FIBER/CAP FUSION ZONE; THE METAL AND GLASS CAPS WERE NOT RETURNED BY THE CUSTOMER. THERE WAS NO INDICATION OR REPORT OF ANY PART OF THE DEVICE REMAINING INSIDE THE PATIENT. THE IDENTIFIED ISSUE MAY ACTIVATE THE FIBERLIFE FUNCTION WHICH WOULD MODULATE THE POWER SHOWING A PULSING BEAM OR THE SYSTEM WOULD BE PLACED INTO STANDBY MODE. THIS ISSUE MAY ALSO CAUSE FORWARD-FIRING. THE PROBABLE ROOT CAUSE OF THE DEVICE FAILURE WAS DETERMINED TO BE HEAT ACCUMULATION DUE TO TISSUE CONTACT AND/OR ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE. REF: MFR 2937094-2013-00159.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING THE SURGICAL FIBER DURING A PROSTATE PROCEDURE, THE FIBER CAP DETACHED AND BECAME LOOSE AT 115,000 JOULES OF USE. THE SECOND FIBER USED ALSO HAD A CAP DETACHMENT AND BECAME LOOSE AT 135,000 JOULES OF USE; HOWEVER, WAS ABLE TO COMPLETE THE CASE. NO PATIENT INJURY REPORTED. THIS REPORT IS FOR THE FIRST FIBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38787 GREENLIGHT MOXY FIBER OPTIC POWERED SURGICAL LASER INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 10-2400 238A

    Patients

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