BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 2973942 · Received February 15, 2013

    Report

    Report Number
    1222780-2013-00033
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    January 18, 2013
    Report Date
    January 18, 2013
    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

    LOT AND SERIAL NUMBER OF THE DISPOSABLE DEVICE NOT PROVIDED BY THE COMPLAINANT, THEREFORE, THE EXPIRATION DATE IS NOT KNOWN. CONCOMITANT MEDICAL PRODUCTS: 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. 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. 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 1 UNSUCCESSFUL CAVITY INTEGRITY ASSESSMENT (CIA) TEST DURING A NOVASURE ENDOMETRIAL ABLATION, THE PHYSICIAN PERFORMED A HYSTEROSCOPY AND SAW "BOWEL AND CAME TO THE CONCLUSION THAT HE PERFORATED THE UTERUS." NO INTERVENTION WAS REQUIRED. THE PROCEDURE WAS ABORTED. 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
    69477 NOVASURE IMPEDANCE CONTROLLED EA SYSTEM MNB HOLOGIC NS2000 UNK

    Patients

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