BEUDAMED
    FDA Adverse Event Death Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 2521400 · Received April 2, 2012

    Report

    Report Number
    1222780-2012-00083
    Event Type
    Death
    Date Received
    April 2, 2012
    Date of Event
    March 1, 2012
    Report Date
    March 20, 2012
    Manufacturer
    HOLOGIC
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. SERIAL NUMBER OF THE RADIO FREQUENCY CONTROLLER NOT PROVIDED BY THE COMPLAINANT. 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) REVIEW WAS UNABLE TO BE CONDUCTED FOR THE DISPOSABLE DEVICE AS THE LOT NUMBER WAS NOT PROVIDED BY THE COMPLAINANT. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) PRECAUTIONS: THE SAFETY AND EFFECTIVENESS OF THE NOVASURE SYSTEM HAS NOT BEEN FULLY EVALUATED IN PTS WHO ARE POST-MENOPAUSAL. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "APPROX 2-3 WEEKS AGO" AN ATTEMPTED NOVASURE ENDOMETRIAL ABLATION, ON AN (B)(6) FEMALE WITH MULTIPLE MEDICAL PROBLEMS, RESULTED IN TWO UNSUCCESSFUL CAVITY INTEGRITY ASSESSMENT (CIA) TESTS. THE PHYSICIAN ABANDONED THE PROCEDURE. NO ELECTRICAL ENERGY WAS APPLIED. NO POST HYSTEROSCOPY WAS DONE. THE PT WAS OBSERVED IN THE RECOVERY ROOM WHERE SHE CONTINUED TO HAVE PAIN. A COMPUTED TOMOGRAPHY (CT) SCAN SUGGESTED BOWEL PERFORATION AND THE PT DEVELOPED AN ACUTE ABDOMEN. FOURTEEN HOURS FOLLOWING THE ATTEMPTED ABLATION A LAPAROSCOPY WAS DONE. "UPON LAPAROSCOPIC ENTRY, FECAL MATTER WAS IDENTIFIED WITHIN THE ABDOMINAL CAVITY." A RECTAL PERFORATION WAS SEEN "THAT APPEARED TO HAVE COME FROM THE POSTERIOR RIGHT CUL-DE-SAC AND EXTENDED THROUGH THE RECTUM". THE PERFORATION WAS "APPROX 1.5CMS IN DIAMETER" AND A "DIVERTING COLOSTOMY WAS PERFORMED". NO UTERINE PERFORATION WAS SEEN. "FOLLOWING THIS SURGERY THE PT BECAME SEPTIC AND EXPIRED APPROX 1 WEEK LATER." WE HAVE BEEN UNABLE TO OBTAIN ADDITIONAL INFO SURROUNDING THIS EVENT. IF ADDITIONAL INFO IS RETURNED A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Death RADIO FREQUENCY CONTROLLER: SERIAL NUMBER UNKNOWN