BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 1972269 · Received January 20, 2011

    Report

    Report Number
    1222780-2011-00014
    Event Type
    Injury
    Date Received
    January 20, 2011
    Date of Event
    December 21, 2010
    Manufacturer
    HOLIGIC
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE REPORTED LOT NUMBER OF THE 2 DISPOSABLE DEVICES. THE LOT WAS RELEASED MEETING ALL QA SPECIFICATIONS. CURRENTLY UNABLE TO ESTABLISH A RELATIONSHIP OR IMPACT TO THE REPORTED OBSERVATION. BASED ON THE INFO OBTAINED TO DATE, NO DIRECT CORRELATION CAN BE MADE BETWEEN THE REPORTED EVENT AND THE NOVASURE SYSTEM. IF ADDITIONAL RELEVANT INFO IS RECEIVED OR DEVICE EVALUATION COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. 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 JUDGEMENT 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

    NOTE: THIS REPORT PERTAINS TO THE SECOND AND THIRD OF THREE HOLOGIC DEVICES USED IN THE SAME PROCEDURE. SEE ASSOCIATED MEDWATCH, MFR'S REPORT NUMBER 1222780-2011-00015. IT WAS REPORTED, FOLLOWING SEVERAL UNSUCCESSFUL CAVITY INTEGRITY ASSESSMENT (CIA) TESTS WITH 2 DISPOSABLE DEVICES DURING A NOVASURE ENDOMETRIAL ABLATION, THE PHYSICIAN DID A HYSTEROSCOPY. SHE DID NOT SEE A UTERINE PERFORATION BUT ABANDONED THE PROCEDURE BECAUSE SHE BELIEVED THERE WAS A POSSIBILITY OF A PERFORATION. NO TREATMENT WAS NEEDED AND THE PT WAS DISCHARGED HOME. ON (B)(6) 2010, THE PHYSICIAN'S OFFICE REPORTED THE DOCTOR HAS BEEN IN TOUCH WITH THE PT AND "SHE IS FINE". A HYSTEROSCOPY WAS PERFORMED PRIOR TO THE ATTEMPTED ABLATION, AS WAS A DILATATION. ADDITIONALLY, A SOUNDING WAS DONE WITH A SURESOUND. IT IS NOT KNOWN WHEN THIS POSSIBLE 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 HOLIGIC NS2000 10G074A (2 DEVICES)

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other RADIO FREQUENCY CONTROLLER - SERIAL NUMBER UNK