BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX

    MDR report key: 424208 · Received October 26, 2002

    Report

    Report Number
    424208
    Event Type
    Injury
    Date Received
    October 26, 2002
    Date of Event
    July 5, 2002
    Report Date
    October 23, 2002
    Manufacturer
    AFX
    Product Code
    HPB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM USER FACILITY 11/27/02: PLEASE DISREGARD MEDWATCH REPORT #0000490118-2002-0022 FOR AFX MEDICAL DEVICE. THIS IS A DUPLICATE REPORT. ORIGINALLY REPORT SUBMITTED 07/19/02, REPORT #0000490118-2002-0020.

    Description of Event or Problem · 1

    AFX FLEX 10 SURGICAL ABLATION PROBE PLACED ON PT BY DOCTOR FOR MINI-MAZE PROCEDURE. PACER SET AT 65 AND TIMER SET AT 90 PER MANUFACTURED RECOMMEDATION. PT WAS NOT YET ON BYPASS BUT AORTIC AND VENOUS CANNULAS WERE IN. DEVICE ACTIVATED-AFTER 35 SECONDS SMOKE WAS NOTED BY DR AND THE ABLATION WAS TERMINATED. THE PROBE HAS AN APPROX 2CM HOLE WITH EXPOSED FINE WIRES. AFX NOTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AFX ABLATION PROBE HPB AFX 102008-02 F02041603

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention