BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 1262790 · Received December 12, 2008

    Report

    Report Number
    1222780-2008-00128
    Event Type
    Injury
    Date Received
    December 12, 2008
    Date of Event
    November 12, 2008
    Report Date
    November 13, 2008
    Manufacturer
    CYTYC SURGICAL PRODUCTS
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE DISPOSABLE DEVICE, AND THE RADIO FREQUENCY CONTROLLER (RFC) INVOLVED IN THIS EVENT. NO ABNORMALITIES WERE FOUND RELATED TO THE REPORTED INFORMATION. THE DISPOSABLE DEVICE AND CONTROLLER PASSED FINAL TESTING PRIOR TO RELEASE. THE DISPOSABLE DEVICE AND THE RFC INVOLVED IN THIS EVENT WERE NOT RETURNED; THEREFORE, AN INVESTIGATION WAS UNABLE TO BE PERFORMED. BASED ON THE INFORMATION OBTAINED TO DATE, NO DIRECT CORRELATION CAN BE MADE BETWEEN THE REPORTED EVENT AND THE NOVASURE SYSTEM.

    Description of Event or Problem · 1

    USER FACILITY REPORTED THAT A SUCCESSFUL NOVASURE PROCEDURE WAS DONE IN 2008. ON POST HYSTEROSCOPY, THE PHYSICIAN NOTICED "A HOLE IN THE TOP OF THE FUNDUS". THE PATIENT WAS ADMITTED TO THE HOSPITAL AND A "SPECIALIST" PERFORMED A LAPAROSCOPY "TO CHECK THE BOWEL AREA". HE NOTED "2 WHITE BLANCHED MARKS, ONE WITH A PERFORATION ON THE TOP OF THE UTERUS". STITCHES WERE PLACED IN THE BOWEL AT THE SIGHT OF THE BLANCH MARKS. THE PATIENT WAS DISCHARGED HOME THE NEXT DAY, AND IS REPORTEDLY "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVASURE IMPEDANCE CONTROLLED EA SYSTEM MNB CYTYC SURGICAL PRODUCTS NS2000 08D05HA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R RADIO FREQUENCY CONTROLLER