BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 1132086 · Received August 21, 2008

    Report

    Report Number
    1222780-2008-00089
    Event Type
    Injury
    Date Received
    August 21, 2008
    Date of Event
    July 22, 2008
    Report Date
    July 22, 2008
    Manufacturer
    CYTYC SURGICAL PRODUCTS
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MFR DATE IS 12/19/07. THIS CODING REFLECTS THE EVAL OF DISPOSABLE DEVICE. DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE REPORTED DEVICE. THIS REVIEW REVEALED NO ABNORMALITIES RELATED TO THE REPORTED INFO. THIS DEVICE PASSED FINAL TESTING PRIOR TO RELEASE. THIS LOT WAS RELEASED MEETING ALL QA SPECS. BASED ON THE INFO OBTAINED TO DATE, NO DIRECT CORRELATION CAN BE MADE BETWEEN THE REPORTED EVENT AND THE NOVASURE DEVICE. 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. (STEP 2.36) ALTHOUGH DESIGNED TO DETECT A PERFORATION OF THE UTERINE WALL, IT (CIA ALARM) IS AN INDICATOR ONLY AND IT MIGHT NOT DETECT ALL PERFORATIONS UNDER ALL POSSIBLE CIRCUMSTANCES. CLINICAL JUDGEMENT MUST ALWAYS BE USED.

    Description of Event or Problem · 1

    USER FACILITY REPORTED UNSUCCESSFUL CAVITY INTEGRITY ASSESSMENT (CIA) TESTS WITH TWO DISPOSABLE NOVASURE DEVICES DUE TO A UTERINE PERFORATION. ADDITIONAL INFO WAS RECEIVED IN 2008. THE PHYSICIAN BECAME AWARE OF A PERFORATION ON POST HYSTEROSCOPY FOLLOWING THE ATTEMPTED ABLATION. THE PERFORATION WAS NOT VISUALIZED BUT THERE WAS A LOSS OF FLUID DURING THE HYSTEROSCOPY LEADING THE PHYSICIAN TO BELIEVE THERE WAS A PERFORATION PRESENT. THERE WAS NO TREATMENT NEEDED AND THE PT WAS DISCHARGED. IT IS NOT KNOWN IF THIS PERFORATION OCCURRED DURING SOUNDING OR ATTEMPTED ABLATION, AND IT IS NOT KNOWN WHAT INSTRUMENT MAY HAVE CAUSED THIS PERFORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVASURE IMPEDANCE CONTROLLED EA SYSTEM MNB CYTYC SURGICAL PRODUCTS NS2000 07K03HA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other LOT NUMBER OF 2ND DEVICE| 1/19/2008. THIS DEVICE IS NOT AVAILABLE FOR EVAL.