BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROBLATE® SYSTEM

    MDR report key: 20348327 · Received October 1, 2024

    Report

    Report Number
    3009970070-2024-00016
    Event Type
    Malfunction
    Date Received
    October 1, 2024
    Date of Event
    September 12, 2024
    Report Date
    October 1, 2024
    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 INSTRUCTIONS FOR USE CONTAIN 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." SECTION 4.6, LASER SAFETY WARNINGS: -"ENSURE THE LASER FIBER CONNECTIONS ARE MADE CORRECTLY. IMPROPER CONNECTIONS MAY LEAD TO EQUIPMENT DAMAGE OR OPERATOR INJURY." SECTION 4.7, INSPECTION, CLEANING, DISINFECTION, STERILIZATION: -"PRIOR TO USE: CAREFULLY INSPECT ALL SYSTEM LASER CABLE/UMBILICAL CONNECTIONS TO ENSURE THEY HAVE ALL COMPLETED THE "TWO-CLICK" CONNECTION, I.E., PLUG IS PUSHED INTO MATING CONNECTOR SO THAT ONE CLICK AT PARTIAL (HALF) INSERTION AND A SECOND CLICK AT FULL INSERTION." NO HARM WAS OBSERVED IN THIS EVENT.

    Description of Event or Problem · 0

    DURING AN ABLATION PROCEDURE, IT WAS REPORTED THAT THE ABLATION BEGAN AS EXPECTED. THE PHYSICIAN PULLED THE LASER BACK FOR ONE MORE POSITION AND INCREASED THE POWER TO 128%. NO HEATING WAS OBSERVED. UPON INSPECTION, IT WAS FOUND THAT THE PORTABLE CONNECTOR MODULE (PCM) TO LASER PROBE CONNECTION WAS THERMALLY DAMAGED. THERE ARE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45245 NEUROBLATE® SYSTEM NEUROBLATE® SYSTEM GEX MONTERIS MEDICAL 20980 00816589021080

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown