BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 1962533 · Received January 6, 2011

    Report

    Report Number
    1222780-2011-00003
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    November 18, 2010
    Report Date
    December 7, 2010
    Manufacturer
    HOLOGIC
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT AND SERIAL NUMBER OF THE DISPOSABLE DEVICE NOT PROVIDED BY THE COMPLAINANT, THEREFORE, THE EXPIRATION DATE IS NOT KNOWN. THE DISPOSABLE DEVICE IS NOT BEING RETURNED THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CAN NOT BE COMPLETED. LOT NUMBER OF THE DISPOSABLE DEVICE NOT PROVIDED BY THE COMPLAINANT, THEREFORE, THE MFR DATE IS NOT KNOWN. EVAL CODES FOR RF CONTROLLER RETURNED FOR EVAL. THE DATE OF MANUFACTURE OF THE RADIO FREQUENCY CONTROLLER IS 10/2006. DEVICE HISTORY RECORD (DHR) AND STERILE LOT RECORD REVIEW COULD NOT BE CONDUCTED FOR THE DISPOSABLE DEVICE AS A LOT AND SERIAL NUMBER WERE NOT PROVIDED BY THE COMPLAINANT. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) OTHER ADVERSE EVENTS: THE FOLLOWING ADVERSE EVENT COULD OCCUR OR HAVE BEEN REPORTED IN ASSOCIATION WITH THE USE OF THE NOVASURE SYSTEM: INFECTION OR SEPSIS. (B)(4).

    Description of Event or Problem · 1

    A PT HAD A NOVASURE ENDOMETRIAL ABLATION ON (B)(6) 2010. THE POST HYSTEROSCOPY WAS NEGATIVE EXCEPT "THE UPPER ENDOCERVICAL CANAL WAS [FOUND TO BE] INADVERTENTLY ABLATED". THE NEXT DAY, (B)(6) 2010, THE PT HAD PAIN AND FEVER OF 101.5 DEGREES FAHRENHEIT. ON THE SECOND DAY SHE FELT BETTER, BUT SHE REPORTED TO THE EMERGENCY ROOM (ER) ON (B)(6) 2010 WITH PAIN. HER PELVIC EXAM AND COMPUTED TOMOGRAPHY (CT) SCAN WERE NEGATIVE. SHE HAD NO FEVER OR ELEVATED WHITE BLOOD CELL (CBC) COUNT. "SHE WAS DISCHARGED HOME [DATE UNK] BUT WAS READMITTED" ON (B)(6) 2010 WITH FEVER AND PROBABLE PNEUMONIA. HER WBC COUNT WAS 20,000 AND BLOOD CULTURES POSITIVE FOR GROUP B STREPTOCOCCUS. SHE BECAME "SEPTIC" AND RESPIRATORY SUPPORT WAS NEEDED AFTER SHE DEVELOPED ARDS (ADULT RESPIRATORY DISTRESS SYNDROME). THE PHYSICIAN REPORTED ON (B)(6) 2010, THAT THIS PT WAS DISCHARGED HOME ON (B)(6) 2010. SHE REPORTED THE "MOST RECENT CT SCAN SHOWED NO EVIDENCE OF GU [GENITOURINARY] OR GI [GASTROINTESTINAL] INJURY FROM NOVASURE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVASURE IMPEDANCE CONTROLLED EA SYSTEM MNB HOLOGIC NS2000 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R RADIO FREQUENCY CONTROLLER: (B)(4)