BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 1893624 · Received November 4, 2010

    Report

    Report Number
    1222780-2010-00168
    Event Type
    Injury
    Date Received
    November 4, 2010
    Date of Event
    September 14, 2010
    Report Date
    October 11, 2010
    Manufacturer
    HOLOGIC
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SERIAL NUMBER OF THE FIRST DISPOSABLE DEVICE NOT PROVIDED BY THE COMPLAINANT. LOT AND SERIAL NUMBER OF THE SECOND DISPOSABLE DEVICE NOT PROVIDED BY THE COMPLAINANT, THEREFORE, THE EXPIRATION DATE IS NOT KNOWN. THE DEVICES ARE NOT BEING RETURNED, THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICES CANNOT BE COMPLETED. LOT NUMBER OF THE SECOND DISPOSABLE DEVICE NOT PROVIDED BY THE COMPLAINANT, THEREFORE, THE MANUFACTURE DATE IS NOT KNOWN. DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE REPORTED LOT NUMBER (10B25R) OF THE FIRST DEVICE. THE LOT WAS RELEASED MEETING ALL QA SPECIFICATIONS. CURRENTLY, UNABLE TO ESTABLISH A RELATIONSHIP OR IMPACT TO THE REPORTED OBSERVATION. STERILE LOT RECORD REVIEW WAS NOT PERFORMED AS THE SERIAL NUMBERS OF THE 2 DEVICES WERE NOT PROVIDED BY THE COMPLAINANT. BASED ON THE INFO OBTAINED TO DATE, NO DIRECT CORRELATION CAN BE MADE BETWEEN THE REPORTED EVENT AND THE NOVASURE SYSTEM. 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

    NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO HOLOGIC DEVICES USED IN THE SAME PROCEDURE. SEE ASSOCIATED MEDWATCH, MFR'S REPORT NUMBER 1222780-2010-00169. DURING A NOVASURE ENDOMETRIAL ABLATION ON (B)(6) 2010, THE FIRST NOVASURE DISPOSABLE DEVICE WAS LEAKING FROM THE "TOP OF THE DEVICE." A SECOND DEVICE COMPLETED THE PROCEDURE SUCCESSFULLY. THE PT RETURNED APPROX 24 HOURS LATER WITH "FEVER AND DISCOMFORT." THE PT WAS LATER ADMITTED TO THE HOSPITAL ON (B)(6) 2010. ULTRASOUND AND COMPUTED TOMOGRAPHY (CT) SCAN WERE INCONCLUSIVE. VAGINAL CULTURES WERE NEGATIVE. THE PT IMPROVED WITH ANTIBIOTICS AND SHE WAS DISCHARGED HOME 2 DAYS LATER. ADDITIONALLY, THE PHYSICIAN REPORTED ON (B)(6) 2010 THAT THE PT WAS SEEN ON FOLLOW-UP AND SHE IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVASURE IMPEDANCE CONTROLLED EA SYSTEM MNB HOLOGIC NS2000 10B25R 1ST DEVICE

    Patients

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