BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEX 10

    MDR report key: 450490 · Received March 24, 2003

    Report

    Report Number
    450490
    Event Type
    Injury
    Date Received
    March 24, 2003
    Date of Event
    March 12, 2003
    Report Date
    March 20, 2003
    Manufacturer
    AFX INC.
    Product Code
    NEY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING ABLATION PROCEDURE A PLUME OF SMOKE WAS NOTED EXITING THROUGH R PORT. ABLATION PROBE REMOVED, WIRE PROTRUDING THROUGH PROBE-MIDSHEATH, WITH SURROUNDING BURN MARKS ON SHEATH. SECOND ABLATION TOOL PLACED; SECOND PLUME OF SMOKE NOTED. SHEATH REMOVED, BURN AGAIN NOTED MIDSHEATH, AND DIFFICULTY SLIDING PROBE OUT. POWER SOURCE HAS BEEN USED SEVERAL TIMES SINCE WITH NO PROBLEMS. NO PT INJURY OR COMPLICATION RELATED TO THIS.

    Description of Event or Problem · 1

    ADD'L INFO RECEIVED FROM REPORTER 4/5/03: NO PT INJURY APPARENT TO DATE.

    Description of Event or Problem · 1

    ADD'L INFO RECEIVED FROM REPORTER 4/15/03: NO PT INJURY APPARENT TO DATE.

    Description of Event or Problem · 1

    TWO PREVIOUS REPORTS WERE SUBMITTED SPECIFIC TO THIS SAME 2003 OCCURRENCE. THE FIRST REPORT SUGGESTED A LIFE THREATENING EVENT. THE SECOND REPORT DELETED THIS INFO AND ONLY INDICATED THAT THE EVENT REQUIRED INTERVENTION. UPON SIGNIFICANT FOLLOW-UP REVIEW AND INVESTIGATION, THIS THIRD AND FINAL REPORT SEEKS TO CLARIFY BOTH POINTS: 1. WITH SMOKE SEEN EXITING THROUGH RIGHT PORT, PT SAFETY WAS AN INITIAL CONCERN (POTENTIAL LIFE-THREATENING CONCERN) HOWEVER, NO PT INJURY WAS, OR HAS IN FACT BEEN NOTED. 2. ALTHOUGH A SECOND PROBE WAS USED TO COMPLETE THE PROCEDURE, NO ACTUAL PT CARE INTERVENTION WAS REQUIRED. HOSP CONTINUES TO BELIEVE THAT THE FILING OF THE MANDATORY REPORT IS APPROPRIATE, SINCE THIS PROVIDES MORE DETAILED INFO TO BOTH THE MFR AND THE FDA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEX 10 SURGICAL ABLATION DEVICE NEY AFX INC. FLEX 10 F0211041

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Life Threatening| R AFX MICROWAVE GENERATOR, MODEL# 1000E.