BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATRICURE WOLF LUMITIP DISSECTOR

    MDR report key: 2190132 · Received January 17, 2007

    Report

    Report Number
    3003502395-2007-00008
    Event Type
    Injury
    Date Received
    January 17, 2007
    Date of Event
    September 21, 2007
    Report Date
    October 16, 2007
    Manufacturer
    ATRICURE, INC.
    Product Code
    FTD
    PMA / PMN Number
    K041681
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFO IS UNK ABOUT ACTUAL DEVICE INVOLVED IN EVENT. THE MOST RECENTLY PURCHASED LOT NUMBERS WERE 12268 AND 12400. EXPIRATION DATE FOR 12400 - 08/2009, 08/2007. EVAL SUMMARY: THE DEVICE INVOLVED IN THE EVENT WAS DISCARDED, SO A RETAINED SAMPLE WAS EVALUATED. A RETAINED SAMPLE WAS NOT AVAILABLE FROM 12400, SO A SAMPLE WAS TESTED FROM 12268. THE RETAINED SAMPLE WAS EVALUATED FOR FUNCTIONALITY WITH NO ISSUES NOTED. THE DEVICE HISTORY RECORD WAS REVIEWED FOR 122268 AND 12400 AND NO ANOMALIES WERE NOTED RELATED TO THIS EVENT.

    Description of Event or Problem · 1

    DURING A CASE, DR (B)(6) OF (B)(6) REGIONAL HEALTH SYSTEM, (B)(6) WAS USING A MID1 TO DISSECT AROUND THE RIGHT PULMONARY VEIN OF A PT AND HE DAMAGED THE VEIN. HE PUT THE PT ON BY-PASS AND PLACED A COUPLE OF SUTURES TO CLOSE THE TEAR. THE CASE WAS COMPLETED USING THE SAME DISSECTOR WITH NO ADDITIONAL ISSUES OR CLINICAL CONSEQUENCE TO THE PT. THE DISSECTOR IS NOT BEING RETURNED BECAUSE THE SURGEON INDICATED THAT THE PRODUCT WAS NOT AT FAULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATRICURE WOLF LUMITIP DISSECTOR DISSECTOR FTD ATRICURE, INC. MID1 12268

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention