BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 1262791 · Received December 12, 2008

    Report

    Report Number
    1222780-2008-00129
    Event Type
    Injury
    Date Received
    December 12, 2008
    Date of Event
    November 10, 2008
    Report Date
    November 13, 2008
    Manufacturer
    CYTYC SURGICAL PRODUCTS
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD (DHR) REVIEWS COULD NOT BE CONDUCTED FOR THE DISPOSABLE DEVICE OR THE RADIO FREQUENCY CONTROLLER (RFC) AS A LOT AND SERIAL NUMBERS WERE NOT PROVIDED BY THE COMPLAINANT. THE DISPOSABLE DEVICE AND THE RFC INVOLVED IN THIS EVENT WERE NOT RETURNED; THEREFORE, AN INVESTIGATION WAS UNABLE TO BE PERFORMED. BASED ON THE INFORMATION OBTAINED TO DATE, NO DIRECT CORRELATION CAN BE MADE BETWEEN THE REPORTED EVENT AND THE NOVASURE SYSTEM. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) UNDER WARNINGS: PATIENTS WHO UNDERGO ENDOMETRIAL ABLATION PROCEDURES WHO HAVE PREVIOUSLY UNDER GONE TUBAL LIGATION ARE AT INCREASED RISK OF DEVELOPING POST ABLATION TUBAL STERILIZATION SYNDROME WHICH CAN REQUIRE HYSTERECTOMY. THIS CAN OCCUR AS LATE AS 10 YEARS POST PROCEDURE.

    Description of Event or Problem · 1

    USER FACILITY REPORTED A SUCCESSFUL NOVASURE ENDOMETRIAL ABLATION IN 2008. SIX TO 8 WEEKS LATER, THE PATIENT APPEARED TO HAVE AN INFECTION IN HER FALLOPIAN TUBES AND WAS ADMITTED TO THE HOSPITAL. DURING FOLLOW-UP WITH THE PHYSICIAN TWO MONTHS LATER, SHE REPORTED THE PATIENT EXPERIENCED FEVER, ANOREXIA, AND WORSENING RIGHT LOWER QUADRANT PAIN AND WAS ADMITTED TO THE HOSPITAL NINE DAYS PRIOR. SHE WAS TAKEN TO THE OPERATING ROOM WHERE IT BECAME EVIDENT THAT THE RIGHT FALLOPIAN TUBE WAS DILATED AND DRAINING. BOTH FALLOPIAN TUBES WERE REMOVED. TREATMENT ALSO INCLUDED CEFTRIAXONE SODIUM, STARTED AT ADMISSION AND FLAGYL (METRONIDAZOLE) BEGUN AFTER SURGERY. THE PATHOLOGY REPORT OF THE FALLOPIAN TUBES SHOWED "INFLAMMATORY CHANGES BUT THE STAINS SHOWED NO BACTERIA OR FUNGUS". CULTURES OF THE RIGHT FALLOPIAN TUBE DRAINAGE WERE NEGATIVE. THE PATIENT WAS DISCHARGED FOUR DAYS LATER, AND IS CURRENTLY DOING FINE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization| R RADIO FREQUENCY CONTROLLER - SERIAL NUMBER - UNK