BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 1962538 · Received January 7, 2011

    Report

    Report Number
    1222780-2011-00007
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 10, 2010
    Manufacturer
    HOLOGIC
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN 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. SHOULD WE RECEIVE THE COMPLAINT DEVICE, A SUPPLEMENTAL MEDWATCH WITH THE RESULTS OF OUR ANALYSIS 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 WARNING OF A POSSIBLE PERFORATION PRIOR TO TREATMENT. REFERENCE INTERNAL COMPLAINT (B)(4).

    Description of Event or Problem · 1

    FOLLOWING AN UNSUCCESSFUL CAVITY INTEGRITY ASSESSMENT (CIA) TEST DURING AN ATTEMPTED NOVASURE ENDOMETRIAL ABLATION, THE PROCEDURE WAS ABANDONED AND A PERFORATION WAS CONFIRMED ON POST HYSTEROSCOPY. THE PT WAS GIVEN A COURSE OF PROPHYLACTIC ANTIBIOTICS AND DISCHARGED HOME. ON (B)(6) 2010 IT WAS REPORTED THAT THE PT HAD BEEN SEEN ON F/U AND WAS "FINE." A HYSTEROSCOPY, DILATATION AND CURETTAGE (D&C), AND SOUNDING WITH A METAL SOUND (NOT A HOLOGIC DEVICE) 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 10H16RC

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other RADIO FREQUENCY CONTROLLER - SERIAL NUMBER UNK