BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROBLATE® SYSTEM

    MDR report key: 20654133 · Received November 11, 2024

    Report

    Report Number
    3009970070-2024-00018
    Event Type
    Malfunction
    Date Received
    November 11, 2024
    Date of Event
    October 25, 2024
    Report Date
    November 11, 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 LASER PROBE CONNECTOR THERMALLY FUSED AT THE PORTABLE CONNECTOR MODULE (PCM) MATING ADAPTER AT THE START OF THE THIRD TRAJECTORY. A BACKUP LASER FIBER CABLE AND A NEW LASER PROBE WAS USED TO COMPLETE THE ABLATION PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1819516 NEUROBLATE® SYSTEM NEUROBLATE® SYSTEM GEX MONTERIS MEDICAL 20980 00816589021080

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown