BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FULLFIRE SELECT 2.2 MM DIFFUSING TIP LASER PROBE

    MDR report key: 5837154 · Received August 1, 2016

    Report

    Report Number
    5837154
    Event Type
    Malfunction
    Date Received
    August 1, 2016
    Date of Event
    July 15, 2016
    Report Date
    July 19, 2016
    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

    A PATIENT WAS UNDER ANESTHESIA FOR A TUMOR ABLATION. MID-SURGERY THE TUMOR ABLATIONS SYSTEM DISPLAYED A MESSAGE THAT THE PROBE WAS NOT CONNECTED OR THE TEMPERATURE SYSTEM NOT ADEQUATE BEFORE THE ABLATION WAS INITIATED. THE MANUFACTURING REPS PRESENT WERE UNABLE TO IDENTIFY THE PROBLEM. THEY CHANGED A POWER CORD AND TESTED A "TEST PROBE". THE LASER WAS REMOVED AND SHOWED VISIBLE SIGNS OF CHARRING WITHOUT EVER BEING USED FOR ABLATION. THE PROCEDURE WAS ABORTED, BUT THE PATIENT WAS NOT HARMED. MANUFACTURER RESPONSE FOR 2.2 MM DIFFUSING TIP LASER PROBE, FULLFIRE SELECT (PER SITE REPORTER): MANUFACTURER HAS REQUESTED ITEM BE GIVEN TO FIELD REP FOR RETURN TO COMPANY FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488839 FULLFIRE SELECT 2.2 MM DIFFUSING TIP LASER PROBE POWERED LASER SURGICAL INSTRUMENT GEX MONTERIS MEDICAL CORP

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR