BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROBLATE

    MDR report key: 8037115 · Received November 5, 2018

    Report

    Report Number
    8037115
    Event Type
    Malfunction
    Date Received
    November 5, 2018
    Date of Event
    September 24, 2018
    Report Date
    November 2, 2018
    Manufacturer
    MONTERIS MEDICAL CORP
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A LASER FIBER CORD ATTACHED TO THE NEUROBLATE PROBE DRIVER BEGAN SMOKING AFTER IT WAS PLUGGED IN AND BEFORE IT HAD ANY CONTACT WITH THE PATIENT. IT WAS REMOVED AND REPLACED WITHOUT FURTHER INCIDENT. THERE WAS NO HARM TO THE PATIENT. MANUFACTURER RESPONSE FOR ABLATION PROBE, NEUROBLADE (PER SITE REPORTER): REP WAS ON SITE DAY OF EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    877268 NEUROBLATE POWERED LASER SURGICAL INSTRUMENT GEX MONTERIS MEDICAL CORP 20368

    Patients

    Seq Age Sex Outcome Treatment
    1