BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 2200787 · Received July 29, 2011

    Report

    Report Number
    1222780-2011-00136
    Event Type
    Injury
    Date Received
    July 29, 2011
    Date of Event
    June 28, 2011
    Report Date
    June 28, 2011
    Manufacturer
    HOLOGIC
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT BEING RETURNED; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE REPORTED LOT NUMBER OF THE DISPOSABLE DEVICE. THE LOT WAS RELEASED MEETING ALL QA SPECIFICATIONS. CURRENTLY UNABLE TO ESTABLISH A RELATIONSHIP OR IMPACT TO THE REPORTED OBSERVATION. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) WARNINGS: USE CAUTION NOT TO PERFORATE THE UTERINE WALL WHEN SOUNDING, DILATING, OR INSERTING THE DISPOSABLE DEVICE. IF THE DISPOSABLE DEVICE IS DIFFICULT TO INSERT INTO THE CERVICAL CANAL, USE CLINICAL JUDGMENT TO DETERMINE WHETHER OR NOT FURTHER DILATION IS REQUIRED. THE NOVASURE SYSTEM PERFORMS A CAVITY INTEGRITY ASSESSMENT (CIA) TEST TO EVALUATE THE INTEGRITY OF THE UTERINE CAVITY, AND SOUNDS AN ALARM WARNING OF A POSSIBLE PERFORATION PRIOR TO TREATMENT. (B)(4).

    Description of Event or Problem · 1

    FOLLOWING 2 UNSUCCESSFUL CAVITY INTEGRITY ASSESSMENT (CIA) TESTS DURING A NOVASURE ENDOMETRIAL ABLATION THE PHYSICIAN VIEWED THE CAVITY VIA A HYSTEROSCOPE AND CONFIRMED A PERFORATION IN THE CENTER OF THE FUNDUS. THE PROCEDURE WAS ABORTED. NO TREATMENT WAS NEEDED FOR THE PERFORATION AND THE PATIENT WAS DISCHARGED HOME. ON (B)(6) 2011, THE PHYSICIAN REPORTED THE PATIENT HAS BEEN SEEN ON FOLLOW-UP AND SHE IS DOING "VERY WELL". A HYSTEROSCOPY, DILATATION, AND SOUNDING WITH A METAL SOUND (NON HOLOGIC DEVICES) WERE PERFORMED PRIOR TO THE ATTEMPTED ABLATION. IT IS NOT KNOWN WHEN THIS PERFORATION OCCURRED OR WHAT INSTRUMENT MAY HAVE BEEN THE CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVASURE IMPEDANCE CONTROLLED EA SYSTEM MNB HOLOGIC NS2000 11C01RC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other RADIO FREQUENCY CONTROLLER: SERIAL NUMBER UNKNOWN