BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOXY

    MDR report key: 21697831 · Received March 26, 2025

    Report

    Report Number
    2124215-2025-17801
    Event Type
    Malfunction
    Date Received
    March 26, 2025
    Date of Event
    January 17, 2025
    Report Date
    April 10, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    GEX
    PMA / PMN Number
    K120870
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT AVAILABLE FOR ANALYSIS; THEREFORE, NO PHYSICAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. THE REPORTED DEVICE PERFORMANCE ALLEGATION CANNOT BE CONFIRMED. BASED ON THE INFORMATION AVAILABLE THE CAUSE THAT CONTRIBUTED TO THE REPORTED EVENT CANNOT BE ESTABLISHED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PHOTOSELECTIVE VAPORIZATION OF THE PROSTATE (PVP) PROCEDURE, AFTER 26:44 MIN AND 202096 JOULES, THE OUTER SHEATH OF THE LASER FIBER APPEARED TO HAVE CRACKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PHOTOSELECTIVE VAPORIZATION OF THE PROSTATE (PVP) PROCEDURE, AFTER 26:44 MIN AND 202096 JOULES, THE OUTER SHEATH OF THE LASER FIBER APPEARED TO HAVE CRACKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1059258 MOXY POWERED LASER SURGICAL INSTRUMENT GEX BOSTON SCIENTIFIC CORPORATION 0010-2400 0034370268

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown