BEUDAMED
    FDA Adverse Event Death Summary report: N

    VERSAPORT V2 FIXATION CANNULA 5MM

    MDR report key: 2621105 · Received June 14, 2012

    Report

    Report Number
    2647580-2012-00359
    Event Type
    Death
    Date Received
    June 14, 2012
    Date of Event
    May 23, 2012
    Report Date
    May 23, 2012
    Manufacturer
    COVIDIEN, FORMERLY USSC
    Product Code
    GCJ
    PMA / PMN Number
    K062326
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: DONOR NEPHRECTOMY. ACCORDING TO THE REPORTER: THE SURGERY BEGAN AT APPROX 8:00 A.M. A HAND ASSIST PORT (NOT COVIDIEN) AND FIVE COVIDIEN TROCARS WERE USED DURING THE CASE. THREE OF THE COVIDIEN TROCARS WERE VERSAPORT V2-5MM (179094F), AND TWO OF THE COVIDIEN TROCARS WERE VERSAPORT V2-12MM (179096PF) TROCAR WAS THEN INSERTED FOR CAMERA ACCESS. THE FELLOW THEN INSERTED ONE OF THE VERSAPORT V2- 5MM (179094F) TROCARS AND REPORTEDLY PUNCTURED THE ABDOMINAL AORTA, AT WHICH TIME BLEEDING OCCURRED. THE PT BEGAN RECEIVING BLOOD WITHIN 15 MINS OF WHEN THE TROCAR PUNCTURED THE AORTA. THE EXACT AMOUNT OF BLOOD LOSS COULD NOT BE REPORTED. THE PROCEDURE WAS SUBSEQUENTLY CONVERTED FROM A LAPAROSCOPIC PROCEDURE TO AN OPEN PROCEDURE TO CONTROL THE BLEEDING. AN ADDITIONAL TRANSPLANT SURGEON CAME INTO THE ROOM TO ASSIST. APPROX 45 MINS LATER, THE NURSE INDICATED THAT THE PT WAS STABLE. AT APPROX 11:10 A.M., THE NURSE INDICATED THAT THE PT CODED. AT APPROX 11:30, THE NURSE INFORMED THE COVIDIEN SALES REPRESENTATIVE THAT THE PT EXPIRED ON THE OPERATING TABLE. ALL 5 COVIDIEN TROCARS WERE COLLECTED AND PLACED IN A PLASTIC BAG. PRODUCT WAS GIVEN TO THE LEGAL DEPARTMENT AT THE ACCOUNT AND WILL NOT BE RELEASED TO COVIDIEN FOR INVESTIGATION AT THIS TIME. FURTHER DETAILS REGARDING THE PT PRE-OPERATIVE DIAGNOSIS, A COPY OF THE OPERATIVE REPORT, PRODUCT LOT NUMBERS, OTHER RELEVANT HISTORY INCLUDING PREEXISTING MEDICAL CONDITIONS, RELEVANT TESTS/LABORATORY DATA, A COPY OF THE AUTOPSY REPORT, ANY EVALUATION OF THE EVENT BY THE ATTENDING PHYSICIAN, SURGEON, HOSPITAL REPRESENTATIVE, OR HEALTHCARE PROFESSIONAL, AND THE PRIMARY AND SECONDARY CAUSE OF DEATH HAVE BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSAPORT V2 FIXATION CANNULA 5MM DISPOSABLE SURGICAL ACCESS DEVICE GCJ COVIDIEN, FORMERLY USSC

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Death