BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 1308555 · Received February 6, 2009

    Report

    Report Number
    1222780-2009-00017
    Event Type
    Injury
    Date Received
    February 6, 2009
    Date of Event
    January 7, 2009
    Report Date
    January 7, 2009
    Manufacturer
    CYTYC SURGICAL PRODUCTS
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE IDENTIFIED LOT NUMBER AND SERIAL NUMBER OF THE DISPOSABLE DEVICE. NO ABNORMALITIES WERE FOUND RELATED TO THE REPORTED INFO. THIS DEVICE PASSED FINAL TESTING PRIOR TO RELEASE. DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE CONDUCTED FOR THE RADIO FREQUENCY CONTROLLER (RFC) AS A SERIAL NUMBER WAS NOT PROVIDED BY THE COMPLAINANT. THE CODING IN THIS SECTION REFLECTS THE EVAL OF THE RETURNED DISPOSABLE DEVICE. THE RADIO FREQUENCY CONTROLLER USED IN THIS EVENT WAS NOT RETURNED FOR TESTING. BASED ON THE INFO 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 A UTERINE PERFORATION AND POSSIBLE BOWEL BURN SEEN ON LAPAROSCOPY FOLLOWING AN ATTEMPTED NOVASURE ABLATION. DURING FOLLOW-UP IN 2009, THE PHYSICIAN REPORTED THAT THE POST LAPAROSCOPY, DONE SIX DAYS PRIOR, REVEALED A "3 CM CONCENTRIC AREA OF CAUTERY ... ON THE UTERINE SEROSA MID-WAY BETWEEN THE FUNDUS AND THE CORNUA ON THE POSTERIOR WALL OF THE UTERUS. IN THIS CIRCLE OF CAUTERIZED SEROSA WAS A 0.5CM PERFORATION SITE". DURING INSPECTION OF THE BOWEL "AN AREA OF MESENTERY ADJACENT TO THE UTERUS" WAS SEEN TO HAVE "A CAUTERY EFFECT BUT THE BOWEL APPEARED NORMAL AND NO FURTHER TREATMENT OR EVAL WAS PERFORMED." THE PT WAS DISCHARGED HOME FOLLOWING THE NOVASURE PROCEDURE AND "HAS HAD NO FURTHER ISSUES 6 DAYS POST-OPERATIVELY". AN INITIAL HYSTEROSCOPY, UTERINE BIOPSY, LAPAROSCOPIC TUBAL LIGATION, A POLYPECTOMY FOLLOWED BY ANOTHER HYSTEROSCOPY, AND A SOUNDING WITH A METAL SOUND (NOT A HOLOGIC DEVICE) WERE PERFORMED PRIOR TO THE NOVASURE PROCEDURE. IT IS NOT KNOWN WHEN THIS PERFORATION OCCURRED OR WHAT 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 08F30HA

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| R RADIO FREQUENCY CONTROLLER - SERIAL NUMBER UNK