BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 18471877 · Received January 8, 2024

    Report

    Report Number
    2124215-2024-00685
    Event Type
    Malfunction
    Date Received
    January 8, 2024
    Date of Event
    December 27, 2023
    Report Date
    March 29, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    GEX
    UDI-DI
    00878953005515
    PMA / PMN Number
    K120870
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT OF THIS FIBER AT OUR QUALITY ASSURANCE LABORATORY, THIS DEVICE WAS THOROUGHLY ANALYZED. VISUAL ANALYSIS IDENTIFIED THAT THE TIR SURFACE IS MISALIGNED WITH THE OUTPUT WINDOW, INDICATING A GLUE FAILURE. THE FIBER WAS FUNCTIONALLY TESTED WITH THE HENE (HELIUM-NEON) LASER FIXTURE. THE TESTING CONDUCTED DID NOT IDENTIFY SIGNS OF BREAKAGE ALONG THE LENGTH OF THE FIBER. FURTHER FUNCTIONAL TESTING TO VERIFY THE FORWARD FIRING OUTPUT RATE SHOWED THAT IT WAS BELOW THE THRESHOLD FOR POTENTIAL PATIENT HARM. THE GLASS CAP EXHIBITED MILD DEVITRIFICATION AND THE METAL CAP EXHIBITED MODERATE DETRITUS ADHESION ON ITS SURFACE, INDICATIVE OF PROLONGED TISSUE CONTACTS. THE MANUFACTURER HAS REVIEWED ALL INFORMATION AND DETERMINED THIS EVENT NO LONGER MEETS REPORTING CRITERIA FOR THE REPORTED FORWARDING FIRING. IT IS PROBABLE THAT THE IDENTIFIED DEBRIS ADHESION ON THE SURFACE OF THE METAL CAP CONTRIBUTED TO ELEVATED TEMPERATURES NEAR THE LASER BEAM OUTPUT WINDOW. CONTINUOUSLY ELEVATED TEMPERATURE CAN LEAD TO FIBER DAMAGES, INCLUDING GLUE FAILURE. THE IFU INSTRUCTS THE USER TO MAINTAIN A WORKING DISTANCE OF 2 MM BETWEEN THE TISSUE AND FIBER TIP DURING USE AND TO INCREASED IRRIGATION FLOW BY MEANS OF A SALINE PRESSURE BAG (SET TO 250 MMHG - 300 MMHG) TO FURTHER INCREASE LIQUID COOLING EFFECT TO REDUCE FIBER TIP DAMAGE. BASED ON ANALYSIS RESULT, THE INTERACTION BETWEEN THE USER AND DEVICE CAUSED OR CONTRIBUTED TO THE OBSERVED FIBER DAMAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A VAPORIZATION PROCEDURE FOR BENIGN PROSTATIC HYPERPLASIA, AT 234 125 JOULES AND 25 MINUTES, THERE WAS A FORWARD FIRING EVENT. DUE TO THIS, THE PROCEDURE WAS COMPLETED USING ANOTHER FIBER. THERE WERE NO PATIENT COMPLICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A VAPORIZATION PROCEDURE FOR BENIGN PROSTATIC HYPERPLASIA, AT 234 125 JOULES AND 25 MINUTES, THERE WAS A FORWARD FIRING EVENT. DUE TO THIS, THE PROCEDURE WAS COMPLETED USING ANOTHER FIBER. THERE WERE NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544003 GREENLIGHT MOXY FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX BOSTON SCIENTIFIC CORPORATION 0010-2400 0031984648 00878953005515

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male