BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFX

    MDR report key: 406016 · Received July 20, 2002

    Report

    Report Number
    406016
    Event Type
    Malfunction
    Date Received
    July 20, 2002
    Date of Event
    July 5, 2002
    Report Date
    July 5, 2002
    Manufacturer
    AFX INC
    Product Code
    NEY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    FLEX 10 SURGICAL ABLATION PROBE PLACED BY DR ON PT FOR MINIMATE PROCEDURE. TIMER SET AT 90 SEC, POWER SET AT 65 PER CO. RECOMMENDATION. AFTER 35 SECS, SURGEON NOTICED SMOKE FROM PROBE AND ABLATION TERMINATED. 2CM HOLE NOTED IN CATHETER WITH BLACK SURROUNDING THE AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AFX FLEX 10 SURGICAL ABLATION DEVICE NEY AFX INC 102008-02 F02041603

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other