BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CANNON VANTAGE TITIAN

    MDR report key: 23787716 · Received December 12, 2025

    Report

    Report Number
    MW5180429
    Event Type
    Injury
    Date Received
    December 12, 2025
    Date of Event
    November 12, 2025
    Report Date
    December 9, 2025
    Manufacturer
    CANON MEDICAL SYSTEMS CORPORATION
    Product Code
    LNH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KS, US
    Reporter Occupation
    501
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT RECEIVED A BURN COMPATIBLE WITH RLE RESTING AGAINST DIACOR MR-TEK350 STAINLESS STEEL PORTION OF STIRRUP. REF#METK3100 DURING MRI (1.5 TESLA CANNON VANTAGE TITAN MACHINE). PATIENT UNDERWENT EPIDURAL FOR HIGH DOSE RADIATION PROCEDURE WHICH REQUIRED PATIENT'S BILATERAL LOWER EXTREMITIES TO BE POSITIONED IN DIACOR STIRRUPS. PATIENT WAS TAKEN TO MRI FOR VERIFICATION OF NEEDLE PLACEMENT. FOLLOWING HDR PROCEDURE NURSING STAFF NOTICED WOUND TO PATIENT'S RIGHT OUTER THIGH. AREA WAS RED WITH A LARGE WHITE/BLANCHED AREA IN THE CENTER RESEMBLING A BURN. PATIENT RETURNED FOR 1 WEEK FOLLOW UP TO HDR PROCEDURE ON (B)(6) 2025 AND REPORTED WORSENING OF WOUND. PATIENT IS REQUIRING CARE AT ADVANCED WOUND CARE CENTER. PER MRI SAFETY OFFICER PATIENT EXPERIENCED "MRI BURN" FROM TOUCHPOINT OF RLE WITH STAINLESS STEEL COMPONENT OF ZEPHYR STIRRUP HINGE. PATIENT WITH EPIDURAL FOR HDR PROCEDURE AND LIKELY DID NOT EXPERIENCE SENSATION OF "BURN" OR PRESSURE DURING MRI TESTING. PT-2696. DEVICE-2919, 4001. REFERENCE REPORT: MW5180428.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2696387 CANNON VANTAGE TITIAN SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING LNH CANON MEDICAL SYSTEMS CORPORATION MTEK3100

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Required Intervention DIACOR MTEK3100 ZEPHRY TABLE.