BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RFA ELEC SINGLE 20 CM X 3 CM

    MDR report key: 2950508 · Received February 5, 2013

    Report

    Report Number
    1717344-2013-00067
    Event Type
    Injury
    Date Received
    February 5, 2013
    Date of Event
    January 11, 2013
    Report Date
    January 11, 2013
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RETURN OF THE INCIDENT SAMPLE HAS BEEN REQUESTED. TO DATE, IT HAS NOT BEEN RECEIVED FOR EVALUATION. ADDITIONAL QUESTIONS IN REGARD TO THE INCIDENT HAVE BEEN ASKED. IF THE SAMPLE IS RECEIVED, OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING AN RF ABLATION PROCEDURE, A LIVER RUPTURE OCCURRED. AT THAT MOMENT LOUD POPPING SOUNDS WERE CONFIRMED AND THE STAFF OBSERVED LARGE BUBBLES AT THE ABLATION SITE IN ULTRASONOGRAPHIC IMAGE. THE RF ABLATION WAS SUSPENDED. TRANSFUSION OF 800ML WAS REQUIRED. AN ANGIOGRAPHY FOR HEMOSTASIS OF INTRAPERITONEAL BLEEDING CAUSED BY LIVER RUPTURE WAS PERFORMED. THE PATIENT IS IN FOLLOW-UP CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49082 RFA ELEC SINGLE 20 CM X 3 CM RF ABLATION ACCESSORY GEI COVIDIEN LP 219710X

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention RFAGENJ ABLATION GENERATOR, S/N (B)(4)