BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXABLATE NEURO

    MDR report key: 13366006 · Received January 27, 2022

    Report

    Report Number
    13366006
    Event Type
    Malfunction
    Date Received
    January 27, 2022
    Date of Event
    November 29, 2021
    Report Date
    December 7, 2021
    Manufacturer
    INSIGHTEC LTD
    Product Code
    POH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    EXABLATE NEURO SILICONE MEMBRANE FAILED CAUSING WATER TO BE PUMPED INTO THE MR SCANNER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296332 EXABLATE NEURO MR-GUIDED FOCUSED ULTRASOUND SYSTEM POH INSIGHTEC LTD 4000 TYPE 1.0 ASC002258

    Patients

    Seq Age Sex Outcome Treatment
    1 18250 DA Male