BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 1289924 · Received January 16, 2009

    Report

    Report Number
    1222780-2009-00003
    Event Type
    Injury
    Date Received
    January 16, 2009
    Date of Event
    December 16, 2008
    Report Date
    December 17, 2008
    Manufacturer
    CYTYC SURGICAL PRODUCTS
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE CONDUCTED FOR THE DISPOSABLE DEVICE AS A LOT NUMBER WAS NOT PROVIDED BY THE COMPLAINANT. DHR REVIEW WAS CONDUCTED FOR THE RADIO FREQUENCY CONTROLLER (RFC). THE DEVICE WAS RELEASED MEETING ALL QA SPECIFICATIONS. NO RELATIONSHIP CAN BE ESTABLISHED TO THE REPORTED COMPLAINT. EXPIRATION DATE OF RFC - NA. BASED ON THE INFORMATION 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. (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 AN UNSUCCESSFUL CAVITY INTEGRITY ASSESSMENT (CIA) TEST A NOVASURE (NS) PROCEDURE WAS ABANDONED. FOLLOWING REMOVAL OF THE DISPOSABLE NS DEVICE THE PHYSICIAN PERFORMED A HYSTEROSCOPY AND CONFIRMED A UTERINE PERFORATION. DURING FOLLOW-UP IN LATE 2008, THE PHYSICIAN REPORTED THE PATIENT WAS ADMITTED TO THE HOSPITAL FOLLOWING THE PROCEDURE. HE REPORTED NO TREATMENT WAS NEEDED AND THE PATIENT WAS DISCHARGED THE NEXT DAY, TWO DAYS PRIOR. THE PHYSICIAN REPORTED THE PATIENT "IS FINE". DURING FOLLOW-UP IN EARLY 2009, THE PHYSICIAN REPORTED A PRE-NOVASURE HYSTEROSCOPY AND A SOUNDING, DONE WITH A METAL SOUND (NOT A HOLOGIC DEVICE), WERE PERFORMED. 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 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization RADIO FREQUENCY CONTROLLER