BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TA30-V3S STAPLER

    MDR report key: 1853949 · Received September 29, 2010

    Report

    Report Number
    2647580-2010-00797
    Event Type
    Malfunction
    Date Received
    September 29, 2010
    Date of Event
    August 31, 2010
    Report Date
    August 31, 2010
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GDW
    PMA / PMN Number
    K013860
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LEFT LUNG LOWER LOBE RESECTION. ACCORDING TO THE REPORTER: INTRAOPERATIVE USE (B)(4) A LOWER LOBE PULMONARY VEIN OCCLUSION, EQUIPMENT OPERATING PROPERLY, HANDLE LOCK CLOSING DEVICE. AFTER THE DEVICE WAS FIRED, THE SURGEON USED A PAIR OF SCISSORS TO CUT ALONG THE DISTAL EDGE VESSELS. THEN PRESSED THE BLACK RELEASE BUTTON, AND JAWS OPENED. THEN, NO STAPLES WERE FOUND ON THE PROXIMAL VASCULAR, LEADING TO SUDDEN INTRAOPERATIVE VENOUS BLEEDING. DIRECTOR IN A TIMELY MANNER CLAMPED THE VASCULAR VESSELS WITH A HEMOSTAT SUTURE. FORTUNATELY, THE BLEEDING WAS A SMALL AMOUNT. THERE WAS NO ADD'L BLEEDING, NO TISSUE DAMAGE, AND OPERATING ROOM TIME WAS NOT EXTENDED OVER 30MINS. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TA30-V3S STAPLER DISPOSABLE SURGICAL STAPLER GDW USSC PUERTO RICO P0D0280

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR