BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE RELOADABLE LINEAR STAPLER

    MDR report key: 128098 · Received October 23, 1997

    Report

    Report Number
    1527736-1997-02723
    Event Type
    Injury
    Date Received
    October 23, 1997
    Date of Event
    September 24, 1997
    Manufacturer
    *
    Product Code
    GAG
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TRACKING #.45722. DEVICE-A. DEVICE NOT RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A PNEUMONECTOMY THE OR TECH SAID THE PULMONARY ARTERY WAS CLEANED, TAKING OFF SMALL VESSELS. THE TX30V WAS PLACED ON THE PULMONARY ARTERY, CLOSED DOWN, AND UPON FIRING IT BEGAN TO BLEED. THEY FIRED ANOTHER STAPLER TRYING TO CONTROL THE BLEEDING. THIS CASE WAS A REOPERATION ON A PT THAT DEVELOPED A BRONCHOPLEURAL FISTULA FROM A LOBECTOMY AND THE DR FEELS IT CAUSED THE BPF. THE ASSISTING DR SAID THEY FIRED TWO TX30VS, CUT IN BETWEEN, AND THEN THE BLEEDING STARTED. THE PRIMARY SURGEON SAID HE THOUGHT MAYBE THEY DID NOT GET ALL OF THE ARTERY IN THE STAPLER SOMEHOW AND SOME OF THE STAPLES DID NOT FIRE. THE SURGEON SAID THE PT IS DOING OK NOW. THE HOSPITAL IS HOLDING ON TO THE INSTRUMENTS FOR NOW. TWO TX30VS ARE BEING HELD. IT IS NOT KNOWN WHICH LOT NUMBER BELONGS TO THE INSTRUMENT WHICH WAS INVOLVED WITH THE BLEEDING PROBLEM 10/8/97 RECEIVED USER FACILITY MEDWATCH REPORT #520083-0006-97 STATING "TWO PROXIMATE VASCULAR STAPLERS WERE PLACED ON THE PULMONARY ARTERY. THE FIRST ONE WAS FIRED AND CAUSED BLEEDING THAT CONTINUED WHEN THE 2ND WAS FIRED. THERE WERE HOLES WHERE THE STAPLES DID NOT CLOSE. THE PT WAS PUT ON BYPASS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE RELOADABLE LINEAR STAPLER RELOADABLE LINEAR STAPLER GAG * NA K46U20

    Patients

    Seq Age Sex Outcome Treatment
    1