BEUDAMED
    FDA Adverse Event Death Summary report: N

    OMRIX BIOPHARMACEUTICALS

    MDR report key: 1166023 · Received September 19, 2008

    Report

    Report Number
    1166023
    Event Type
    Death
    Date Received
    September 19, 2008
    Date of Event
    August 22, 2008
    Report Date
    September 11, 2008
    Manufacturer
    Y.S.M. MEDICAL & REHABILITATION EQUIPEMENT LTD., SHEBA HOSPITAL
    Product Code
    CAN
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING SURGERY SPECULUM WAS PLACED IN VAGINA, CERVIX NOTED TO HAVE ACTIVE BLEEDING, ACTIVE BLEEDING ALSO NOTED FROM THE ENDOCERVICAL CANAL. DIAGNOSTIC HYSTEROSCOPY WAS PERFORMED USING SORBITAL 3% SOLUTION AND CONTINUOUS VIDEO MONITORING. THE UTERUS WAS FOUND TO BE SOUNDING TO 6 CM. THERE WAS BLEEDING COMING FROM THE EXOCERVIX AT ABOUT 8:30 AND ALSO SOME COMING FROM THE CERVICAL CANAL. DIAGNOSTIC HYSTEROSCOPY SHOWED NORMAL LINING INSIDE THE WALL OF THE UTERUS WITH ONE AREA OF CLOT WHICH WAS ATTACHED TO THE BACK WALL OF THE UTERUS. HYSTEROSCOPE WAS REMOVED. CURETTAGE OF THE ENDOMETRIUM WAS PERFORMED. HYSTEROSCOPY WAS REPEATED, NO ACTIVE BLEEDING WAS NOTED. ATTENTION WAS THEN TURNED TO OBTAINING HEMOSTASIS OF CERVIX. THIS WAS COAGULATED AND EVICEL WAS SPRAYED ON EXOCERVIX ONLY AND THE VERY MOST SUPERFICIAL PART OF ENDOCERVICAL CANAL. AS THE PROCEDURE WAS CONCLUDING AND WITHIN APPROX ONE MINUTE OF THE EVICEL SPRAY, THE PATIENT'S HEART STOPPED. CARDIOPULMONARY RESUSCITATION WAS PERFORMED. CHEST X-RAY NOTED LARGE AMOUNT OF AIR IN THE LEFT VENTRICLE AND WITHIN THE AORTA, ALSO AIR NOTED IN THE PORTAL VENOUS SYSTEM WITHIN THE LIVER; PATCHY BILATERAL PULMONARY INFILTRATES, NO PNEUMOTHORAX. THE RESUSCITATION ULTIMATELY INCLUDED OPEN CHEST RESUSCITATION WITH CARDIOPULMONARY BYPASS. PATIENT DID NOT RESPOND AND WAS PRONOUNCED DEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMRIX BIOPHARMACEUTICALS PRESSURE REGULATOR CAN Y.S.M. MEDICAL & REHABILITATION EQUIPEMENT LTD., SHEBA HOSPITAL

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Death OLYMPUS LENS 5MM A22000A| STOPCOCK KARL STORZ 27502 LOT LG CE RV| OBTURATOR A47610A 6.5MM| OLYMPUS HYSTEROSCOPE (SAME DATE AND SURGERY)