BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 2974368 · Received February 19, 2013

    Report

    Report Number
    2937094-2013-00248
    Event Type
    Malfunction
    Date Received
    February 19, 2013
    Date of Event
    November 20, 2012
    Report Date
    December 21, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K100746
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPONENT CODES FIBER AND CAP REFER TO THE RESULT CODE THERMAL PROBLEM. FIBER ANALYSIS: THE METAL CAP WAS FOUND TO BE SEPARATED FROM THE FIBER. ADDITIONALLY, A CIRCUMFERENTIAL FRACTURE OF THE GLASS CAP WAS FOUND, DISTAL TO THE FIBER/CAP FUSION ZONE; THE FIBER PROXIMAL TO THE FRACTURE SEPARATED FROM THE METAL CAP. BURNT ON DETRITUS AND DEVITRIFICATION OF THE CAP OUTPUT WINDOW WAS ALSO OBSERVED. BOTH CAPS REMAIN INTACT AND ATTACHED. THE RETURNED FIBER CARD WAS VERIFIED WITH 133,559 JOULES OF USE; EXPIRATION OF THE FIBER CARD WAS NOT CONFIRMED. THE IDENTIFIED ISSUES 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 MOST 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.

    Additional Manufacturer Narrative · 1

    THE COMPONENT CODES FIBER AND CAP REFER TO THE RESULT CODE THERMAL PROBLEM. FIBER ANALYSIS: THE METAL CAP WAS FOUND TO BE SEPARATED FROM THE FIBER. ADDITIONALLY, A CIRCUMFERENTIAL FRACTURE OF THE GLASS CAP WAS FOUND, DISTAL TO THE FIBER/CAP FUSION ZONE; THE FIBER PROXIMAL TO THE FRACTURE SEPARATED FROM THE METAL CAP. BURNT ON DETRITUS AND DEVITRIFICATION OF THE CAP OUTPUT WINDOW WAS ALSO OBSERVED. BOTH CAPS REMAIN INTACT AND ATTACHED. THE RETURNED FIBER CARD WAS VERIFIED WITH 133,559 JOULES OF USE; EXPIRATION OF THE FIBER CARD WAS NOT CONFIRMED. THE IDENTIFIED ISSUES 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 MOST 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGICAL FIBER WAS NOT FIRING CORRECTLY; IT WAS FURTHER REPORTED THAT THE FIBER WAS ROTATING INSIDE THE FIBER CAP. THE CASE WAS COMPLETED USING A SECOND FIBER. THERE WAS NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72506 GREENLIGHT MOXY FIBER OPTIC POWERED SURGICAL LASER INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 10-2400 225A

    Patients

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