BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANON

    MDR report key: 23832810 · Received December 17, 2025

    Report

    Report Number
    2025632-2025-00010
    Event Type
    Malfunction
    Date Received
    December 17, 2025
    Date of Event
    November 18, 2025
    Report Date
    February 3, 2026
    Manufacturer
    CANON MEDICAL SYSTEMS CORPORATION
    Product Code
    OWB
    UDI-DI
    04987670100192
    PMA / PMN Number
    K210900
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ROOT CAUSE ANALYSIS: SYSTEM ERROR OCCURRED USING STENT ENHANCER FUNCTION, AFTER SELECTING F-STORE BEFORE CLOSING FUNCTION. SYSTEM ERROR RELATED TO SOFTWARE ERROR. CORRECTIVE ACTIONS: MANUFACTURER TO PROVIDE REVISED SOFTWARE TO PREVENT RECURRENCE. ACTIONS TAKEN TO PREVENT RECURRENCE: IDENTIFY AND CORRECT ANY CODE THAT ACCESSES ARRAYS USING ARGUMENTS. CHECK ARGUMENT RANGES IN NEW CODE TO PREVENT OUT-OF-BOUNDS ACCESS (ADDED TO CODE REVIEW PERSPECTIVE).

    Description of Event or Problem · 0

    DURING USE OF STENT ENHANCE ON (B)(6) 2025 THE SYSTEM LOCKED UP. AFTER SYSTEM LOCK UP, STAFF FORCED SHUTDOWN AND WAS ABLE TO REBOOT ONLY AFTER MULTIPLE ATTEMPTS. DURING THIS TIME, TOTALING MORE THAN 30 MINUTES STAFF WERE UNABLE TO PERFORM FLUORO OR DA AND PATIENT WENT INTO CARDIAC ARREST. AFTER SYSTEM REBOOT THE SYSTEM OPERATED NORMALLY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Description of Event or Problem · 0

    DURING USE OF STENT ENHANCE ON (B)(6) 2025 THE SYSTEM LOCKED UP. AFTER SYSTEM LOCK UP STAFF FORCED SHUTDOWN AND WAS ABLE TO REBOOT ONLY AFTER MULTIPLE ATTEMPTS. DURING THIS TIME, TOTALING MORE THAN 30 MINUTES STAFF WERE UNABLE TO PERFORM FLUORO OR DA AND PATIENT WENT INTO CARDIAC ARREST. AFTER SYSTEM REBOOT THE SYSTEM OPERATED NORMALLY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2181690 CANON INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB CANON MEDICAL SYSTEMS CORPORATION INFX-8000C/Z1 04987670100192

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening