BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 3001333 · Received March 6, 2013

    Report

    Report Number
    1222780-2013-00042
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    January 23, 2013
    Report Date
    February 4, 2013
    Manufacturer
    HOLOGIC
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 DEVICE IS NOT BEING RETURNED THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. LOT NUMBER OF THE DISPOSABLE DEVICE NOT PROVIDED BY THE COMPLAINANT, THEREFORE, THE MANUFACTURE DATE IS NOT KNOWN. DEVICE HISTORY RECORD (DHR) AND STERILE LOT RECORD REVIEW WERE UNABLE TO BE CONDUCTED FOR THE DISPOSABLE DEVICE AS THE LOT NUMBER WAS NOT PROVIDED BY THE COMPLAINANT. BASED ON THE INFORMATION OBTAINED TO DATE, NO DIRECT CORRELATION CAN BE MADE BETWEEN THE REPORTED EVENT AND THE NOVASURE SYSTEM. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2013, A PATIENT HAD AN UNEVENTFUL NOVASURE ENDOMETRIAL ABLATION. "ON POST-ABLATION HYSTEROSCOPY, THERE WAS GOOD CAUTERY EFFECT THROUGH THE ENDOMETRIAL CAVITY." THE PATIENT WAS DISCHARGED HOME. ON (B)(6) 2013, THE PATIENT RETURNED TO THE EMERGENCY ROOM "COMPLAINING OF NAUSEA AND VOMITING." THE PATIENT ALSO EXHIBITED "UTERINE TENDERNESS AND WAS STARTED ON ORAL DOXYCYCLINE AND METRONIDAZOLE FOR PRESUMED ENDOMETRITIS." THE PATIENT WAS DISCHARGED HOME. ON (B)(6) 2013, THE PATIENT RETURNED TO THE HOSPITAL WITH WORSENING SYMPTOMS AND WAS ADMITTED. SHE WAS PUT ON INTRAVENOUS ANTIBIOTICS: ZOSYN (PIPERACILLIN) AND METRONIDAZOLE. AN ULTRASOUND WAS PERFORMED AND REVEALED AN "8CM COMPLEX CYSTIC STRUCTURE WAS IDENTIFIED POSTERIOR TO THE UTERUS SUGGESTIVE OF A TUBO-OVARIAN ABSCESS." THE PATIENT'S WHITE BLOOD CELL COUNT WAS ELEVATED, BUT NO SIGNIFICANT FEVER. "ALL CULTURES WERE NEGATIVE. SHE REMAINED ON INTRAVENOUS ANTIBIOTICS AND IMPROVED WITHOUT NEED FOR FURTHER INTERVENTION." THE PATIENT WAS DISCHARGED ON (B)(6 )2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95384 NOVASURE IMPEDANCE CONTROLLED EA SYSTEM MNB HOLOGIC NS2000 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| R RADIO FREQUENCY CONTROLLER: SERIAL #UNK