BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOXY

    MDR report key: 22543426 · Received July 18, 2025

    Report

    Report Number
    2124215-2025-47777
    Event Type
    Malfunction
    Date Received
    July 18, 2025
    Date of Event
    June 3, 2025
    Report Date
    September 19, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    GEX
    UDI-DI
    00878953005515
    PMA / PMN Number
    K120870
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THIS FIBER WAS THOROUGHLY ANALYZED. VISUAL INSPECTION DID NOT FIND VISIBLE DEFECTS ON THE FIBER BODY. THE HENE (HELIUM-NEON) FUNCTIONAL TEST FOUND NO BREAKS ALONG THE FIBER LENGTH. THE FIBER PASSED THE CONNECTOR SEGMENT VERIFICATION AND THE SALINE FLOW TEST. REVIEW OF THE FIBER CARD DATA INDICATED THAT THE FIBER WAS RECOGNIZED AND USED. A SOFT JOULE LIMIT WAS ISSUED, WHICH IS NOT A FAILURE. IT IS THE POINT AT WHICH FIBER REMOVAL FROM THE CONSOLE WOULD INVALIDATE FURTHER FIBER USAGE. HOWEVER, MICROSCOPE INSPECTION OF THE FIBER TIP IDENTIFIED THAT THE METAL CAP AND GLAS CAP WERE DETACHED/SEPARATED. THEREFORE, THE REPORTED EVENT WAS CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PHOTOSELECTIVE VAPORIZATION OF THE PROSTATE, THE FIBER TIP RUPTURED AFTER USING 170727 JOULES AND 18 MINUTES OF FIBER USED. THE PROCEDURE WAS COMPLETED USING ANOTHER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PHOTOSELECTIVE VAPORIZATION OF THE PROSTATE, THE FIBER TIP RUPTURED AFTER USING 170727 JOULES AND 18 MINUTES OF FIBER USED. THE PROCEDURE WAS COMPLETED USING ANOTHER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PHOTOSELECTIVE VAPORIZATION OF THE PROSTATE, THE FIBER TIP RUPTURED AFTER USING 170727 JOULES AND 18 MINUTES OF FIBER USED. THE PROCEDURE WAS COMPLETED USING ANOTHER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED. IT WAS IDENTIFIED THAT THE FIBER CAP TIP WAS DETACHED UPON RECEIPT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401196 MOXY POWERED LASER SURGICAL INSTRUMENT GEX BOSTON SCIENTIFIC CORPORATION 0010-2400 0035176445 00878953005515

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown