BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFX FLEX 10

    MDR report key: 452307 · Received April 3, 2003

    Report

    Report Number
    MW1028057
    Event Type
    Malfunction
    Date Received
    April 3, 2003
    Manufacturer
    AFX INC.
    Product Code
    NEY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO RECEIVED FROM RPTR 5/22/03: PT'S PROCEDURE WAS CONVERTED FROM ENDOSCOPIC TO SMALL THORACOTOMY, SURGEON STATES THIS CONVERSION WAS NOT IN FACT RELATED TO THE USE OF THE PROBE, RATHER IT WAS SECONDARY TO THE FACT THAT A SMALL AMOUNT OF BLEEDING OCCURRED FROM THE USE OF A STAPLER.

    Description of Event or Problem · 1

    DURING ABLATION PROCEDURE, PLUME OF SMOKE NOTED FROM PORT. PROBE REMOVED. BURN MARKS NOTED MIDSHAFT OF SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AFX FLEX 10 SURGICAL ABLATION DEVICE NEY AFX INC. * FO3012302-09

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR