BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 2926292 · Received January 18, 2013

    Report

    Report Number
    1222780-2013-00007
    Event Type
    Injury
    Date Received
    January 18, 2013
    Date of Event
    December 20, 2012
    Report Date
    December 20, 2012
    Manufacturer
    HOLOGIC
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES HAVE NOT YET BEEN RETURNED; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICES CANNOT BE COMPLETED. IF THE DEVICES ARE RETURNED AND EVALUATION COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. 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 OF A POSSIBLE PERFORATION PRIOR TO TREATMENT. (B)(4).

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO HOLOGIC DEVICES USED IN THE SAME PROCEDURE. SEE ASSOCIATED MEDWATCH MFR'S REPORT #: 1222780-2013-00006. FOLLOWING SEVERAL CAVITY INTEGRITY ASSESSMENT (CIA) TESTS WITH 2 DISPOSABLE DEVICES DURING A NOVASURE ENDOMETRIAL ABLATION THE PHYSICIAN DID A HYSTEROSCOPY AND NOTED A PERFORATION "AT THE LEFT CORNUA OF THE FUNDUS." THE NOVASURE PROCEDURE WAS ABORTED. NO TREATMENT WAS NEEDED AND THE PT WAS DISCHARGED HOME. ON (B)(6) 2012, IT WAS REPORTED THAT THE PT IS "DOING FINE." A HYSTEROSCOPY AND DILATATION (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
    28213 NOVASURE IMPEDANCE CONTROLLED EA SYSTEM MNB HOLOGIC NS2000 12G02R (2 DEVICES)

    Patients

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