BEUDAMED
    FDA Adverse Event Other Summary report: N

    VARIAN INTELLIBLATE MICROWAVE ABLATION SYSTEM

    MDR report key: 22010749 · Received May 13, 2025

    Report

    Report Number
    MW5170256
    Event Type
    Other
    Date Received
    May 13, 2025
    Date of Event
    May 6, 2025
    Report Date
    May 6, 2025
    Manufacturer
    VARIAN MEDIAL SYSTEMS, INC.
    Product Code
    NEY
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    VARIAN MEDICAL SYSTEMS INTELLIBLATE MICROWAVE ABLATION OF KIDNEY TUMOR WAS BEING PERFORMED. DEVICE FAILED DURING ABLATION. PROBE HAD TO BE REPLACED, CAUSING DELAY IN ABLATION, LONGER ANESTHESIA TIME AND POSSIBLE INEFFECTIVE ABLATION. LOT: 31726, 13G X 15 CM MICROWAVE PROBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1825622 VARIAN INTELLIBLATE MICROWAVE ABLATION SYSTEM SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES NEY VARIAN MEDIAL SYSTEMS, INC. IB-XPA-1315 31726

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Other