BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 1202949 · Received October 16, 2008

    Report

    Report Number
    1222780-2008-00105
    Event Type
    Injury
    Date Received
    October 16, 2008
    Date of Event
    September 12, 2008
    Report Date
    September 16, 2008
    Manufacturer
    CYTYC SURGICAL PRODUCTS
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE RADIO FREQUENCY CONTROLLER. THE DEVICE WAS RELEASED MEETING ALL QA SPECIFICATIONS. CURRENTLY UNABLE TO ESTABLISH A RELATIONSHIP OR IMPACT TO THE REPORTED OBSERVATION. DEVICE HISTORY RECORD (DHR) REVIEW FOR THE DISPOSABLE DEVICE COULD NOT BE CONDUCTED AS A LOT NUMBER WAS NOT PROVIDED BY THE COMPLAINANT. THE DISPOSABLE DEVICE AND RADIO FREQUENCY CONTROLLER INVOLVED IN THIS EVENT WERE NOT RETURNED; THEREFORE, AN INVESTIGATION WAS UNABLE TO BE PERFORMED IN OUR LAB. 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 "SMALL BURNING IN THE CORNUA OF THE UTERUS AND PART OF THE BOWEL" FOLLOWING A NOVASURE PROCEDURE. THE PHYSICIAN PROVIDED ADD'L WRITTEN INFO ON 09/25/2008. HE REPORTED THE PT WAS ADMITTED 9 DAYS POST UTERINE ABLATION IN 2008, WITH AN "ACUTE ABDOMEN". ON LAPAROSCOPY 2 ESCHARS WERE FOUND IN THE UTERUS, "ONE OF 0.5MM IN THE LEFT CORNUA AND ANOTHER ONE OF 0.3MM IN THE RIGHT CORNUA" AND A BOWEL PERFORATION WAS FOUND IN THE JEJUNUM, MEASURING 0.3MM. NO UTERINE PERFORATION WAS SEEN. TREATMENT ON THAT DAY INCLUDED "RESECTION OF 20CM OF THE JEJUNUM" WITH ANASTOMOSIS. THE POST OPERATIVE PATHOLOGY REPORT REVEALED "SEGMENT OF INTESTINE WITH SEROUS TARNISH, AND WITH VIOLET-COLORED FIBRO-PURULENT DEPOSITS... NO MACROSCOPIC ALTERATIONS OF THE MUCOSA WERE OBSERVED." "MARKED EDEMA TO ISCHEMIC OF THE SECONDARY SUBMUCOSA - PERITONITIS FIBRINO-PURULENT." THE PT WAS DISCHARGED "AT 7 DAYS".

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization| O| R RADIO FREQUENCY CONTROLLER