BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOXY

    MDR report key: 24458908 · Received February 26, 2026

    Report

    Report Number
    2124215-2026-10818
    Event Type
    Malfunction
    Date Received
    February 26, 2026
    Date of Event
    February 5, 2026
    Report Date
    April 1, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    GEX
    UDI-DI
    00878953005515
    PMA / PMN Number
    K120870
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6). THE DEVICE IS NOT AVAILABLE FOR ANALYSIS; THEREFORE, NO PHYSICAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. THE PRODUCT RECORD REVIEW (PRR) RESULTS DETAILED IN THE PRR TABLE DID NOT DETERMINE THE PROBABLE CAUSE. THE DEVICE HISTORY RECORD (DHR) REVIEW CONFIRMED THAT THE DEVICE MET SPECIFICATION PRIOR TO SHIPPING. NO MANUFACTURING DEVIATIONS WERE NOTED THAT COULD HAVE CONTRIBUTED TO THE EVENT REPORTED. A LABELLING REVIEW WAS PERFORMED ON THE DEVICE INSTRUCTIONS FOR USE (IFU). THE IFU CITED THAT THE FIBER IS A PRECISION DEVICE. DAMAGE TO THE FIBER CAN RESULT IN THE EMISSION OF UNCONTROLLED LASER ENERGY. DO NOT EXCESSIVELY MANIPULATE OR BEND THE FIBER. A RISK REVIEW WAS COMPLETED AND CONFIRMED THAT THE EVENT OF THE FIBER BREAK AND FORWARD FIRING WAS DEFINED IN THE RISK DOCUMENTATION AND IS DOCUMENTED ACCORDINGLY IN THE PRR. THIS EVENT TYPE HAS BEEN ACCOUNTED FOR DURING PRODUCT RISK ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFIT FOR THE PRODUCT. BASED ON THE INFORMATION AVAILABLE, THE CONCLUSION CODE "UNABLE TO EXCLUDE DEVICE PROBLEM" HAS BEEN ASSIGNED AS THE MOST PROBABLE CAUSE.

    Additional Manufacturer Narrative · 0

    BLOCK E1: (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PROCEDURE, THE METAL CAP DETACHED FROM THE TIP OF THE FIBER, GENERATING A DIRECT EMISSION OF THE BEAM. THE PROCEDURE WAS COMPLETED WITH ANOTHER FIBER. THERE WERE NO PATIENT COMPLICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PROCEDURE, THE METAL CAP DETACHED FROM THE TIP OF THE FIBER, GENERATING A DIRECT EMISSION OF THE BEAM. THE PROCEDURE WAS COMPLETED WITH ANOTHER FIBER. THERE WERE NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320629 MOXY POWERED LASER SURGICAL INSTRUMENT GEX BOSTON SCIENTIFIC CORPORATION 0010-2400 0035670050 00878953005515

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown