BEUDAMED
    FDA Adverse Event Death Summary report: N

    OLYMPUS MEDICAL SYSTEMS CORP.

    MDR report key: 2869351 · Received November 28, 2012

    Report

    Report Number
    2869351
    Event Type
    Death
    Date Received
    November 28, 2012
    Date of Event
    November 7, 2012
    Report Date
    November 26, 2012
    Product Code
    HIF
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A (B)(6) FEMALE ADMITTED FOR ELECTIVE LAPAROSCOPIC HYSTERECTOMY DUE TO HISTORY OF FIBROIDS. SHE WAS TAKING SIMVASTIN AND AMLODIPINE FOR HYPERTENSION AND CHOLESTEROL BUT NO OTHER SIGNIFICANT MEDICAL HISTORY KNOWN. THE PROCEDURE BEGAN WITH THE USE OF THE CO2 INSUFFLATOR TO INFLATE THE ABDOMINAL CAVITY. THE USE OF THE INSUFFLATOR THROUGHOUT THE PROCEDURE CONTINUED AS PLANNED WITH ALL ROUTINE LAPAROSCOPIC PROCEDURES. THE SURGEON APPLIED THE EVICEL CLOSURE PRODUCT AND BEGAN CLOSING THE WOUNDS, WHEN THE PATIENT WENT SUDDENLY INTO ASYSTOLE AND THEN VENTRICULAR TACHYCARDIA. (B)(6) PROTOCOL WAS STARTED IMMEDIATELY. AFTER SEVERAL ATTEMPTS TO RESUSCITATE THE PATIENT, THE PATIENT WAS PRONOUNCED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS MEDICAL SYSTEMS CORP. INSUFFLATOR HIF UHI-3

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Death EQUIPMENT HAS BEEN TAKEN OUT OF SERVICE SINCE THE| ACTUAL EVENT.