BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOXY

    MDR report key: 21665133 · Received March 21, 2025

    Report

    Report Number
    2124215-2025-17128
    Event Type
    Malfunction
    Date Received
    March 21, 2025
    Date of Event
    February 25, 2025
    Report Date
    May 21, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    GEX
    UDI-DI
    00878953005515
    PMA / PMN Number
    K120870
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    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 DID NOT IDENTIFY ANY DEFECTS. 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. THE FUNCTIONAL TESTING CONDUCTED CONCLUDED THAT FIRING OUTPUT RATE WAS BELOW THE THRESHOLD FOR POTENTIAL PATIENT HARM. THE MANUFACTURER HAS REVIEWED ALL THE INFORMATION AND DETERMINED THIS EVENT NO LONGER MEETS REPORTING CRITERIA FOR THE REPORTED FORWARDING FIRING. IT IS PROBABLE THAT THE DEBRIS ADHESION IDENTIFIED ON THE SURFACE OF THE METAL CAP CONTRIBUTED TO ELEVATED TEMPERATURES NEAR THE LASER BEAM OUTPUT WINDOW. CONTINUOUSLY ELEVATED TEMPERATURE CAN LEAD TO FIBER DAMAGE. THE IFU INSTRUCTS THE USER TO MAINTAIN A WORKING DISTANCE OF 2 MM BETWEEN THE TISSUE AND FIBER TIP DURING USE AND TO INCREASE 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 RESULTS, 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 THE FIBER STARTED FORWARD FIRING AT 170270 J AFTER 25 MINUTES OF THE PHOTOVAPORIZATION OF THE PROSTATE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE FIBER STARTED FORWARD FIRING AT 170270 J AFTER 25 MINUTES OF THE PHOTOVAPORIZATION OF THE PROSTATE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    900226 MOXY POWERED LASER SURGICAL INSTRUMENT GEX BOSTON SCIENTIFIC CORPORATION 0010-2400 0034464859 00878953005515

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male