BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 2833124 · Received November 7, 2012

    Report

    Report Number
    1222780-2012-00238
    Event Type
    Injury
    Date Received
    November 7, 2012
    Date of Event
    October 8, 2012
    Report Date
    October 8, 2012
    Manufacturer
    HOLOGIC
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 AND MYOSURE HYSTEROSCOPE 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. IFU, 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 EVAL 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 A SUCCESSFUL MYOSURE PROCEDURE FOR UTERINE TISSUE REMOVAL, THE PHYSICIAN BEGAN A NOVASURE ENDOMETRIAL ABLATION. THE ABLATION WAS ABORTED AFTER A CAVITY INTEGRITY ASSESSMENT (CIA) TEST WAS UNSUCCESSFUL AND A HYSTEROSCOPY REVEALED A "VERY SMALL PERFORATION". NO TREATMENT WAS NEEDED FOR THE PERFORATION AND THE PT WAS DISCHARGED HOME. ON (B)(6) 2012, IT WAS REPORTED THE PT "IS DOING FINE." A 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other RADIO FREQUENCY CONTROLLER - SERIAL #UNK| MYOSURE HYSTEROSCOPE - SERIAL #UNK