BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONTERIS MEDICAL NEUROBLATE SYSTEM

    MDR report key: 4718094 · Received April 22, 2015

    Report

    Report Number
    3009970070-2015-00003
    Event Type
    Malfunction
    Date Received
    April 22, 2015
    Date of Event
    October 30, 2014
    Report Date
    October 30, 2014
    Manufacturer
    MONTERIS MEDICAL CORPORATION
    Product Code
    GEX
    PMA / PMN Number
    K120561
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONNECTOR MODULE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, THIS TYPE OF EVENT WAS ABLE TO BE RECREATED IN LABORATORY STUDIES. THE LIKELY ROOT CAUSE OF THIS EVENT IS DEBRIS IN THE FIBER OPTIC CONNECTORS WITHIN THE CONNECTOR MODULE.

    Additional Manufacturer Narrative · 1

    MONTERIS MEDICAL INITIATED A VOLUNTARY MARKET WITHDRAWAL FOR THE NEUROBLATE® SYSTEM'S CONNECTOR MODULE ON 09MAY2017 IN ORDER TO ROTATE-OUT THE EXISTING CONNECTOR MODULE WITH THE ENHANCED PORTABLE CONNECTOR MODULE. MONTERIS' PORTABLE CONNECTOR MODULE RECEIVED FDA 510(K) CLEARANCE ON 07APR2017 VIA K170724.

    Description of Event or Problem · 1

    THIS REPORT IS BEING SUBMITTED TO FOLLOW-UP TO A USER FACILITY REPORT RECEIVED BY MONTERIS MEDICAL. APPROXIMATELY ELEVEN MINUTES INTO TREATMENT (AFTER ADMINISTERING THERAPY WITH NO ISSUES), A SUDDEN DECLINE IN TISSUE TEMPERATURE WAS NOTED VIA READINGS FROM THE THERMOCOUPLE IN THE LASER PROBE. WITH THE TEMPERATURE SLOWLY DECREASING, THE USER RELEASED THE FOOT PEDAL (DEACTIVATING THE LASER), LET THE MRI RUN FOR TWO MEASUREMENTS, AND RESUMED TREATMENT WITH NO EFFECT. THERAPY WAS STOPPED AT THIS POINT AS NO ENERGY WAS MAKING IT INTO THE TARGET AREA. THE MONTERIS CLINICAL SPECIALIST WENT TO INSPECT THE PROBE CONNECTIONS AND WHEN ENTERING THE ROOM NOTICED AN ODOR SIMILAR TO "BURNT PLASTIC". UPON FURTHER INVESTIGATION, THE LASER FIBER CONNECTION FROM THE PROBE HAD FUSED (MELTED) TO THE CONNECTOR MODULE AT THE INTERFACE PLATFORM. THE PROBE AND CONNECTOR MODULE WERE REPLACED AND THE CASE PROGRESSED IN ACCORDANCE WITH EXPECTATIONS. THERE WAS NO PATIENT IMPACT RESULTING FROM THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268119 MONTERIS MEDICAL NEUROBLATE SYSTEM POWERED LASER SURGICAL INSTRUMENT GEX MONTERIS MEDICAL CORPORATION 20360

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR