BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 1033821 · Received April 24, 2008

    Report

    Report Number
    1222780-2008-00047
    Event Type
    Injury
    Date Received
    April 24, 2008
    Date of Event
    March 7, 2008
    Report Date
    March 25, 2008
    Manufacturer
    CYTYC SURGICAL PRODUCTS
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE REPORTED LOT NUMBER. THE LOT WAS RELEASED MEETING ALL QA SPECIFICATIONS. CURRENTLY UNABLE TO ESTABLISH A RELATIONSHIP OR IMPACT TO THE REPORTED OBSERVATION. THE DEVICE INVOLVED IN THIS EVENT WAS NOT RETURNED; THEREFORE, AN INVESTIGATION WAS UNABLE TO BE PERFORMED.

    Description of Event or Problem · 1

    USER FACILITY REPORTED, A SUCCESSFUL NOVASURE PROCEDURE IN 2008. THE PT WAS DISCHARGED HOME. THE NEXT DAY, THE PATIENT RETURNED TO THE HOSP WITH AN ELEVATED TEMPERATURE. SHE WAS GIVEN ANTIBIOTICS (NAME OF MEDICATION UNKNOWN) FOR POSSIBLE ENDOMETRITIS AND SENT HOME. SHE WAS CALLED BACK TO THE HOSP THE SAME DAY AND ADMITTED WHEN BLOOD CULTURES RETURNED POSITIVE FOR E-COLI (ESCHERICHIA COLI) AND STREP (STREPTOCOCCUS) FAECALIS. INTRAVENOUS (IV) ANTIBIOTICS (NAME OF MEDICATION UNKNOWN) WERE ADMINISTERED. TWO DAYS LATER, A LAPAROSCOPY WAS PERFORMED WHICH REVEALED NO ACUTE PELVIC INFLAMMATORY DISEASE (PID), NORMAL TUBES [FALLOPIAN] AND OVARIES, NO PERFORATION, NO PUS OR FECAL MATERIAL IN ABDOMINAL CAVITY. NO PELVIC TRAUMA OR ABDOMINAL INJURY NOTED, GALL BLADDER SLIGHTLY DISTENDED. A HYSTEROSCOPY DONE ON THE SAME DAY REVEALED NO PUS IN THE UTERINE CAVITY. ON THE SAME DAY, SHE WAS TRANSFERED TO A HIGH DEPENDENCY UNIT AS HER CONDITION DETERIORATED. TWO DAYS LATER, SHE IMPROVED AND MOVED BACK TO A REGULAR HOSP UNIT. SHE REMAINED HOSPITALIZED UNTIL FIVE DAYS LATER, DUE TO "CHEST COMPLICATIONS". THE PHYSICIAN REPORTED, SHE HAS "NO CONCERNS ABOUT THE ROLE NOVASURE PLAYED IN THIS SITUATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVASURE IMPEDANCE CONTROLLED EA SYSTEM RADIO FREQUENCY ENDOMETRIAL ABLATION MNB CYTYC SURGICAL PRODUCTS NS2000 07G30H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other