BEUDAMED
    FDA Adverse Event Death Summary report: N

    AUTO SUTURE VERSAPORT

    MDR report key: 35947 · Received August 20, 1996

    Report

    Report Number
    35947
    Event Type
    Death
    Date Received
    August 20, 1996
    Date of Event
    August 16, 1996
    Report Date
    August 19, 1996
    Manufacturer
    UNITED STATES SURGICAL CORP.
    Product Code
    GCJ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS ANESTHESTIZED WITHOUT DIFFICULTY, AND PREPPED AND DRAPED FOR LAPARSCOPIC CHOLECYSTECTOMY. ABDOMEN INSUFFLATED WITH CO2 TO NORMAL DISTENSION. UMBILICAL PORT INSERTED AND ABDOMEN EXAMINED WITH NORMAL FINDINGS. UPPER MIDLINE PORT INSERTED IN USUAL LOCATION, AND BRISK BLEEDING NOTED JUST ABOVE PYLORIC VEIN. THIS WAS TAMPONADED WITH PRESSURE USING SURGICAL GAUZE. NO FURTHER BLEEDING NOTED. WITHIN ONE OR TWO MINUTES, BLOOD PRESSURE DROPPED TO 40MM HG. WHOLE BLOOD IMMEDIATELY STARTED WITH PRESSURE. CENTRAL VENOUS LINE PLACED IN LEFT FEMORAL VEIN, PRESSURE CONTINUED TO DROP. CARDIAC ARREST OCCURRED. THE HEART FAILED TO START AND ABDOMEN WAS ENTERED VIA UPPER MIDLINE INCISION (PORTS HAD BEEN REMOVED FOR SHOCKING). WHEN SURGEON ENTERED ABDOMEN, CONSIDERABLE BLOOD CLOTS WERE NOTED IN RIGHT AND LEFT GUTTERS. AORTA WAS MOBILIZED AND STELLATE 0.5 CM PUNCTURE WOUND WAS FOUND AT LEVEL OF UPPER PYLORUS. PT PRONOUNCED, PROCEDURE TERMINATED, AND FAMILY NOTIFIED BY PHYSICIANS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTO SUTURE VERSAPORT DISPOSABLE TROCAR GCJ UNITED STATES SURGICAL CORP. 179070 N6F90

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Death
    2