BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROBLATE

    MDR report key: 3624949 · Received December 12, 2013

    Report

    Report Number
    3009970070-2013-00010
    Event Type
    Malfunction
    Date Received
    December 12, 2013
    Date of Event
    November 14, 2013
    Report Date
    December 12, 2013
    Manufacturer
    MONTERIS MEDICAL CORP
    Product Code
    GEX
    PMA / PMN Number
    K131278
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SIDE-FIRE PROBE (S/N: (B)(4)) WAS DAMAGED UPON OPENING. THE PILOT LIGHT OF THE PROBE WAS INSPECTED PRIOR TO INSERTION AND WAS NOT AS INTENSE AS THE STANDARD SFP, BUT VISIBLE TO THE USER. IN TREATMENT MONITORING, THE USER BEGAN TO FIRE THE LASER AND STAYED ON THE PEDAL FOR ABOUT 30 SECONDS AFTER LASER WAS ACTIVATED AND NO HEAT WAS SEEN. THE PROBE WAS IN THE PROPER LOCATION AS COLD PIXELS WERE SEEN CHANGING DUE TO COOLING, BUT NO HEAT. THE TREATMENT WAS STOPPED AND ALL OF THE FIBER CONNECTION POINTS WERE INSPECTED FOR HEAT LOSS WITH NOTHING ABNORMAL DETECTED. EACH CONNECTION WAS THEN RESEATED. NEXT, THE FIBER BUNDLE CONNECTION FROM THE PANEL TO IP WAS EXCHANGED, THE LASER RESET, AND TREATMENT WAS RESUMED. THE USER THEN STAYED ON THE PEDAL FOR APPROXIMATELY ANOTHER MINUTE WITH NO HEATING SEEN, ONLY TISSUE COOLING. IT WAS FINALLY DETERMINED THAT THE PROBE WAS FAULTY. THE PROBE WAS SCRAPPED AT THIS POINT AND KEPT BY RISK MANAGEMENT AT THE HOSPITAL AND WILL BE RETURNED TO MONTERIS MEDICAL AFTER INVESTIGATION. NO HARM TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651417 NEUROBLATE GEX - POWERED LASER SURGICAL INSTRUMENT GEX MONTERIS MEDICAL CORP 20368-1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR