BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 1321407 · Received February 19, 2009

    Report

    Report Number
    1222780-2009-00019
    Event Type
    Injury
    Date Received
    February 19, 2009
    Date of Event
    January 4, 2009
    Report Date
    January 20, 2009
    Manufacturer
    CYTYC SURGICAL PRODUCTS
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE CONDUCTED FOR THE DISPOSABLE DEVICE AS A LOT # WAS NOT PROVIDED BY THE COMPLAINANT. THE DISPOSABLE DEVICE WAS NOT RETURNED FOR EVALUATION AS IT WAS DISCARDED BY THE USER FACILITY AFTER THE UNEVENTFUL PROCEDURE. IT IS NOT KNOWN WHICH OF THE 2 RADIO FREQUENCY CONTROLLERS (RFC) AT THE SITE WAS USED DURING THIS PROCEDURE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR BOTH CONTROLLERS REVEALED NO ABNORMALITIES AND BOTH PASSED ALL INSPECTION CRITERIA FOR RELEASE. DEVICE MANUFACTURE DATE: 04/2005; 06/2005. 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 SUCCESSFUL NOVASURE (NS) PROCEDURE IN LATE 2008. APPROXIMATELY 1 WEEK LATER, THE PT CALLED AND REPORTED DISCOMFORT. THE PT WAS ADMITTED TO THE HOSP AND TAKEN TO SURGERY. A "PINPOINT THERMAL INJURY [WAS] NOTICED AT THE TOP OF THE FUNDUS". DURING F/U IN 2009, THE PHYSICIAN REPORTED THE PT CALLED POST NS ABLATION WITH NAUSEA, VOMITING, AND LOW GRADE FEVER AND WAS HOSPITALIZED THE MONTH PRIOR. A COMPUTED TOMOGRAPHY (CT) SCAN WAS INDICATIVE OF THERMAL INJURY. ON LAPAROSCOPY "2 TINY AREAS OF BURN WERE SEEN ON THE OUTSIDE AND TOP OF THE UTERUS (NOT PERFORATIONS) AND ONE SMALL SPOT OF THERMAL INJURY WAS SEEN ON THE SMALL INTESTINE. A BOWEL RESECTION WAS DONE AT THIS SITE." THE PT REMAINED HOSPITALIZED FOR 8-9 DAYS AND WAS DISCHARGED HOME (EXACT DATE UNK). ADDITIONALLY, THE PHYSICIAN REPORTED HE HAS BEEN IN CONTACT WITH THE PT BY PHONE AND "SHE IS DOING FINE".

    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 44 YR Hospitalization| R RADIO FREQUENCY CONTROLLER