BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 1307905 · Received February 4, 2009

    Report

    Report Number
    1222780-2009-00012
    Event Type
    Injury
    Date Received
    February 4, 2009
    Date of Event
    January 5, 2009
    Report Date
    January 5, 2009
    Manufacturer
    CYTYC SURGICAL PRODUCTS
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE 2 DISPOSABLE DEVICES, BOTH LOT NUMBER 08G07HA, AND SERIAL NUMBER (B)(4). NO ABNORMALITIES WERE FOUND RELATED TO THE REPORTED INFO. THESE DEVICES PASSED FINAL TESTING PRIOR TO RELEASE. THE CODING IN THIS SECTION REFLECTS THE EVAL OF BOTH DISPOSABLE DEVICES REPORTEDLY USED IN THIS PROCEDURE. BASED ON THE INFO OBTAINED TO DATE, NO DIRECT CORRELATION CAN BE MADE BETWEEN THE REPORTED EVENT AND THE NOVASURE SYSTEM. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) UNDER THE WARNINGS SECTION: 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). ADDITIONAL SERIAL #: (B)(4).

    Description of Event or Problem · 1

    USER FACILITY REPORTED THAT FOLLOWING SEVERAL UNSUCCESSFUL CAVITY INTEGRITY ASSESSMENT (CIA) TESTS, WITH 2 DISPOSABLE NOVASURE DEVICES, IT WAS DETERMINED THERE WAS A UTERINE PERFORATION AND THE PROCEDURE WAS ABANDONED. DURING FOLLOW-UP ON (B)(6) 2009, THE PHYSICIAN REPORTED SHE DID A LAPAROSCOPY FOLLOWING THE NOVASURE PROCEDURE AND CONFIRMED A PERFORATION IN THE RIGHT SIDE OF THE UTERINE FUNDUS. SHE CAUTERIZED THE SITE AND THE PT WAS KEPT OVERNIGHT FOR OBSERVATION. SHE WAS DISCHARGED THE NEXT DAY ((B)(6) 2009). THE PHYSICIAN REPORTED THE PT HAS BEEN SEEN ON FOLLOW-UP AND IS DOING FINE. THE PHYSICIAN REPORTED SHE DID A HYSTEROSCOPY, A DILATATION AND CURETTAGE (D&C), AND A SOUNDING WITH A METAL SOUND (NOT A HOLOGIC DEVICE) PRIOR TO THE NOVASURE PROCEDURE. 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 CYTYC SURGICAL PRODUCTS NS2000 08G07HA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization| R RADIO FREQUENCY CONTROLLER - SERIAL NUMBER UNK