BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 2921934 · Received January 11, 2013

    Report

    Report Number
    1222780-2013-00015
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    December 12, 2012
    Report Date
    December 12, 2012
    Manufacturer
    HOLOGIC
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SERIAL NUMBER OF THE RADIO FREQUENCY CONTROLLER WAS NOT PROVIDED BY THE COMPLAINANT. THE DEVICE IS NOT BEING RETURNED THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE REPORTED LOT NUMBER. THE LOT WAS NOT 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

    PRIOR TO A NOVASURE ENDOMETRIAL ABLATION, THE PHYSICIAN PERFORMED A HYSTEROSCOPY AND "UPON VIEW, HE SAW MANY ADHESIONS IN THE CAVITY AND HAD DIFFICULTY LOCATING THE TUBAL OSTIA." THE PHYSICIAN "RELEASED SOME OF THE ADHESIONS" AND "ATTEMPTED TO PLACE AN ESSURE BUT IT LAID FLAT IN THE CAVITY AFTER RELEASE." THE ESSURE WAS REMOVED AND THE ESSURE PROCEDURE WAS ABORTED. THE PHYSICIAN THEN PERFORMED A NOVASURE ENDOMETRIAL ABLATION. FOLLOWING 2 UNSUCCESSFUL CAVITY INTEGRITY ASSESSMENT (CIA) TESTS, THE PHYSICIAN DID A HYSTEROSCOPY AND A LAPAROSCOPY AND SAW TWO PERFORATIONS (LOCATION UNK). THE NOVASURE PROCEDURE WAS ABORTED AT THIS TIME. THE NOVASURE PROCEDURE WAS ABORTED AT THIS TIME. NO MEDICAL INTERVENTION WAS REQUIRED. THE PT WAS DISCHARGED HOME ON PROPHYLACTIC ANTIBIOTICS. A HYSTEROSCOPY, 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
    19032 NOVASURE IMPEDANCE CONTROLLED EA SYSTEM MNB HOLOGIC NS2000 12F07RA

    Patients

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