BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 2870154 · Received December 5, 2012

    Report

    Report Number
    1222780-2012-00260
    Event Type
    Injury
    Date Received
    December 5, 2012
    Date of Event
    November 5, 2012
    Report Date
    November 5, 2012
    Manufacturer
    HOLOGIC
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    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 RECORDS (DHR) REVIEW WAS CONDUCTED FOR THE REPORTED LOT NUMBER. THE LOT WAS RELEASED MEETING ALL QA SPECIFICATION. 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

    IT WAS REPORTED THAT PRIOR TO A NOVASURE ENDOMETRIAL ABLATION THE PHYSICIAN DID A HYSTEROSCOPY AND NOTED AN ANTEVERTED UTERUS WITH "THIN, ATROPIC ENDOMETRIUM." THE DEVICE WAS SEATED IN THE UTERINE CAVITY AND THE PHYSICIAN RECEIVED AN UNSUCCESSFUL CAVITY INTEGRITY ASSESSMENT (CIA) TEST. SHE AGAIN DID A HYSTEROSCOPY AND SAW A 6MM UTERINE PERFORATION AT THE FUNDUS. THE NOVASURE PROCEDURE WAS ABORTED. NO TREATMENT WAS NEEDED AND THE PATIENT WAS DISCHARGED HOME. A HYSTEROSCOPY, DILATATION, AND SOUNDING WITH A METAL SOUND (NOT 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 12D12RA

    Patients

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