BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROBLATE® SYSTEM

    MDR report key: 14116329 · Received April 14, 2022

    Report

    Report Number
    3009970070-2022-00013
    Event Type
    Malfunction
    Date Received
    April 14, 2022
    Date of Event
    March 18, 2022
    Report Date
    June 29, 2022
    Manufacturer
    MONTERIS MEDICAL
    Product Code
    GEX
    UDI-DI
    00816589021080
    PMA / PMN Number
    K193375
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE NEUROBLATE SYSTEM INSTURCTIONS FOR USE, REVISION B (CURRENT) CONTAINS LASER SAFETY WARNINGS AS RISK MITIGATIONS FOR THIS EVENT: SECTION 4.3, GENERAL WARNINGS: "LASER EYE PROTECTION PROVIDED WITH THE NEUROBLATE SYSTEM MUST BE WORN IN THE MRI SCANNER ROOM DURING OPERATION OF THE LASER". "TO AVOID EQUIPMENT DAMAGE AND PATIENT INJURY, DO NOT CONTINUE TO DELIVER LASER ENERGY IF NO ELEVATION IN TISSUE TEMPERATURE IS OBSERVED." "TO AVOID EQUIPMENT DAMAGE AND PATIENT INJURY, DO NOT CONTINUE TO DELIVER LASER ENERGY IF NO ELEVATION IN TISSUE TEMPERATURE IS OBSERVED. NO HARM WAS OBSERVED IN THIS EVENT OR ANY PREVIOUSLY REPORTED EVENT, AND THE EVENT DESCRIPTION PROVIDED BY THE CLINICAL SPECIALIST INDICATES THAT THESE INSTRUCTIONS FOR RISK MITIGATION WERE FOLLOWED. THEREFORE, THESE RISK MITIGATIONS REMAIN EFFECTIVE.

    Description of Event or Problem · 0

    DURING AN ABLATION PROCEDURE, IT WAS REPORTED THAT NO TEMPERATURE INCREASE WAS DISPLAYED ON THERMAL SCAN. THE CLINICAL SPECIALIEST FOUND THAT THIS WAS LIKELY CAUSED BY A DAMAGED CONNECTION BETWEEN THE PORTABLE CONNECTOR MODULE (PCM) AND THE MRI CONTROL ROOM PENETRATION PANEL. THERE WERE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2043988 NEUROBLATE® SYSTEM NEUROBLATE® SYSTEM GEX MONTERIS MEDICAL 20980 00816589021080

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown