BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYTYC SURGICAL PRODUCTS

    MDR report key: 661840 · Received November 26, 2005

    Report

    Report Number
    MW1037607
    Event Type
    Injury
    Date Received
    November 26, 2005
    Date of Event
    November 17, 2005
    Report Date
    November 23, 2005
    Manufacturer
    CYTYC CORP
    Product Code
    MNB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    PT WAS UNDERGOING OUTPATIENT SURGERY FOR AN ENDOMITRIAL ABLATION DUE TO MERORRHAGIA. DR PERFORMED THE PROCEDURE USING THE NOVASURE EQUIPMENT/ TECHNIQUE MANUFACTURED BY CYTYC CORP. AFTER APPOX 15 MINUTES INTO THE PROCEDURE AND EXACTLY WHEN DR DEPRESSED THE FOOT PEDAL SWITCH ON THE NOVASURE EQUIPMENT, WHICH PRODUCED HIGHER ELECTRICAL CURRENTS TO BETTER CAUTERIZE THE BLOOD VESSELS, THE PT FLAT LINED AND REQUIRED CPR COMPRESSIONS TO BE BROUGHT BACK TO LIFE. THE PROCEDURE WAS STOPPED AND THE MACHINE TAKEN OUT OF SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYTYC SURGICAL PRODUCTS NOVASURE MNB CYTYC CORP * *

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Life Threatening| R