BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 1241524 · Received November 21, 2008

    Report

    Report Number
    1222780-2008-00115
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    October 21, 2008
    Report Date
    October 23, 2008
    Manufacturer
    CYTYC SURGICAL PRODUCTS
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD (DHR) REVIEWS WERE CONDUCTED FOR THE DISPOSABLE DEVICE AND RFC. THESE DEVICES WERE RELEASED MEETING ALL QA SPECS. CURRENTLY UNABLE TO ESTABLISH A RELATIONSHIP OR IMPACT TO THE REPORTED OBSERVATION. THIS CODING REFLECTS THE EVAL OF THE DISPOSABLE DEVICE. THE RADIO FREQUENCY CONTROLLER WAS NOT RETURNED. BASED ON THE INFO OBTAINED TO DATE, NO DIRECT CORRELATION CAN BE MADE BETWEEN THE REPORTED EVENT AND THE NOVASURE SYSTEM.

    Description of Event or Problem · 1

    USER FACILITY REPORTED "THE DOCTOR STARTED THE NOVASURE PROCEDURE AND THE PT'S HEART STOPPED BEATING AND THE PROCEDURE WAS ABORTED." THE UTERINE ABLATION HAD BEEN "IN PROCESS FOR ABOUT 65 SECONDS". DURING FOLLOW-UP IN 2008, IT WAS REPORTED THE PT WAS TREATED WITH ATROPINE, EPINEPHRINE, AND CHEST COMPRESSIONS FOR 10 SECONDS UNTIL HER HEART RHYTHM RETURNED. THE "PT WAS DISCHARGED AFTER A SHORT RECOVERY PERIOD". ADDITIONAL FOLLOW-UP WAS RECEIVED FIVE DAYS LATER FROM THE PHYSICIAN'S OFFICE. THE PHYSICIAN'S ASSISTANT REPORTED "THE PT HAS NO HISTORY OF HEART DISEASE". THE PT HAS BEEN SEEN IN THE OFFICE FOR FOLLOW-UP AND "IS DOING FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVASURE IMPEDANCE CONTROLLED EA SYSTEM MNB CYTYC SURGICAL PRODUCTS NS2000 08D24HB

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention RADIO FREQUENCY CONTROLLER