BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FULLFIRE SELECT DIFFUSING TIP LASER PROBE

    MDR report key: 6510580 · Received April 21, 2017

    Report

    Report Number
    6510580
    Event Type
    Malfunction
    Date Received
    April 21, 2017
    Date of Event
    September 21, 2016
    Report Date
    April 20, 2017
    Manufacturer
    MONTERIS MEDICAL CORP
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING MEDIAL TEMPORAL LOBE ABLATION DURING CRANIOSTOMY, THE PROBE WAS PLACED AND THE THERMOCOUPLE WAS NOT REGISTERING PROPERLY. THIS PROBE WAS DISCARDED. A SECOND PROBE WAS PLACED, AND THE THERMOCOUPLE WAS MEASURING APPROPRIATELY. THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293034 FULLFIRE SELECT DIFFUSING TIP LASER PROBE POWERED LASER SURGICAL INSTRUMENT GEX MONTERIS MEDICAL CORP 20624-5

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR