BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 1103703 · Received August 8, 2008

    Report

    Report Number
    1222780-2008-00085
    Event Type
    Injury
    Date Received
    August 8, 2008
    Date of Event
    July 10, 2008
    Report Date
    July 10, 2008
    Manufacturer
    CYTYC SURGICAL PRODUCTS
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REFLECT THE INVESTIGATION OF THE RFC. THE DISPOSABLE DEVICE HAS NOT YET BEEN RECEIVED. DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE DISPOSABLE DEVICE AND RADIO FREQUENCY CONTROLLER. NO ABNORMALITIES WERE NOTED RELATED TO THE REPORTED INFO. THE PRODUCTS WERE RELEASED MEETING ALL QA SPECIFICATIONS. BASED ON THE INFO OBTAINED TO DATE, NO DIRECT CORRELATION CAN BE MADE BETWEEN THE REPORED EVENT AND THE NOVASURE SYSTEM. ACCORDING TO THE INSTRUCTIONS FOR (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 THAT FOLLOWING THE SEATING OF A NOVASURE DISPOSABLE DEVICE NO GREEN OR RED LIGHT ILLUMINATED TO INDICATE A PASSED OR FAILED CAVITY INTEGRITY ASSESSMENT (CIA) TEST. THE DEVICE WAS REMOVED AND THE PHYSICIAN PERFORMED A LAPAROSCOPY AND NOTED A UTERINE PERFORATION. THE PT WAS DISCHARGED HOME FOLLOWING THE ATTEMPTED ABLATION. IN 2008, IT WAS REPORTED THAT THE PHYSICIAN DID NOT KNOW IF HER PERFORATED THE UTERUS WITH THE SOUND (NOT A HOLOGIC DEVICE) OR WITH THE DISPOSABLE NOVASURE DEVICE. ADDITIONALLY, IT WAS REPORTED THE PT EXPERIENCED "MODERATE PAIN" AT THE TIME OF THIS EVENT BUT IS DOING "FINE" NOW. IN 2008, ADDITIONAL INFO WAS RECEIVED FROM THE PHYSICIAN. HE REPORTED THERE WERE 2 PERFORATIONS, ONE ON EACH SIDE OF THE UTERUS. NO TREATMENT WAS NEEDED FOR THE PERFORATIONS AND HE PROCEEDED WITH A LAPAROSCOPIC TUBAL LIGATION PRIOR TO DISCHARGING THE PT. HE REPORTED THE PT HAS NOT YET RETURNED TO HIS OFFICE FOR FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVASURE IMPEDANCE CONTROLLED EA SYSTEM MNB CYTYC SURGICAL PRODUCTS NS2000 08C14HA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention RADIO FREQUENCY CONTROLLER (RFC) MODEL 09