BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 1923565 · Received December 10, 2010

    Report

    Report Number
    1222780-2010-00194
    Event Type
    Injury
    Date Received
    December 10, 2010
    Date of Event
    November 11, 2010
    Report Date
    November 11, 2010
    Manufacturer
    HOLOGIC
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SERIAL NUMBER OF THE DISPOSABLE DEVICE NOT PROVIDED BY THE COMPLAINANT. 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. BASED ON THE INFO OBTAINED TO DATE, NO DIRECT CORRELATION CAN BE MADE BETWEEN THE REPORTED EVENT AND THE NOVASURE SYSTEM. DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE REPORTED LOT NUMBER. 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 A FAILED CAVITY INTEGRITY ASSESSMENT (CIA) TEST DURING AN ATTEMPTED NOVASURE ENDOMETRIAL ABLATION PROCEDURE, THE PROCEDURE WAS ABANDONED AS A "SMALL" PERFORATION WAS CONFIRMED ON POST LAPAROSCOPY. THE PHYSICIAN THEN PERFORMED A HYSTERECTOMY FOR STERILIZATION AND MENORRHAGIA. THE PATIENT WAS ADMITTED PRIOR TO THE NOVASURE PROCEDURE FOR BREAST CANCER SURGERY AS WELL AS THE NOVASURE PROCEDURE AND A TUBAL LIGATION. THE PATIENT WAS DISCHARGED ON (B)(6) 2010. ON (B)(6) 2010, THE PHYSICIAN REPORTED THAT THE PATIENT HAS BEEN SEEN ON F/U AND WAS "FINE". A HYSTEROSCOPY WAS PERFORMED PRIOR TO THE ATTEMPTED ABLATION, AS WAS A DILATATION AND SOUNDING WITH A METAL SOUND (NOT A HOLOGIC DEVICE). 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 10G17MA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other RADIO FREQUENCY CONTROLLER - SERIAL NUMBER UNK