BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXABLATE NEURO

    MDR report key: 13365994 · Received January 27, 2022

    Report

    Report Number
    13365994
    Event Type
    Malfunction
    Date Received
    January 27, 2022
    Date of Event
    November 16, 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 DURING TREATMENT, PUMPED WATER INTO ENERGIZED MRI SCANNER.

    Description of Event or Problem · 0

    EXABLATE NEURO SILICONE MEMBRANE FAILED DURING TREATMENT, PUMPED WATER INTO ENERGIZED MRI SCANNER. NO HARM TO THE PATIENT OR PROVIDERS OCCURRED. THE PROCEDURE WAS STOPPED. THE VENDOR WAS PRESENT AT THE TIME OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296324 EXABLATE NEURO MR-GUIDED FOCUSED ULTRASOUND SYSTEM POH INSIGHTEC LTD 4000 TYPE 1.0 ASC002258-AA

    Patients

    Seq Age Sex Outcome Treatment
    1 25185 DA Female