BEUDAMED
    FDA Adverse Event Death Summary report: N

    1 PROXIMATE RELOADABLE LINEAR STAPLER

    MDR report key: 3212733 · Received July 1, 2013

    Report

    Report Number
    MW5030784
    Event Type
    Death
    Date Received
    July 1, 2013
    Date of Event
    June 24, 2013
    Report Date
    July 1, 2013
    Manufacturer
    JOHNSON AND JOHNSON
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    (B)(6) ARRIVED BY EMS W/ SINGLE 5.0 CM DEEP STAB WOUND TO UPPER BACK AT 22:31. PT WAS LETHARGIC W/ SEVERE RESPIRATORY DISTRESS, HYPOTENSION AND TACHYCARDIA. HE BECAME UNRESPONSIVE IN ED AND TRAUMA SERVICE WAS CALLED. A THORACOTOMY WAS PERFORMED AND PERFUSE BLOOD AND CLOTS REMOVED FROM CHEST CAVITY. AT 22:55: BLOOD PRODUCTS GIVEN AND PT WAS TAKEN TO OPERATING ROOM EMERGENTLY W/ CHEST OPEN AND HAND IN CHEST HOLDING PRESSURE ON THE AORTA. WHILE IN SURGERY, THE MD REPAIRED THE LEFT INFERIOR PULMONARY VEIN USING A RELOADABLE LINEAR STAPLER. THE STAPLER PERFORMED APPROPRIATELY. AFTER ROTATING THE LUNG TO THE MIDLINE, THE PULMONARY VEIN TEAR WAS FOUND TO EXTEND TO THE PRIMARY PULMONARY VEIN. THE STAPLER WAS RELOADED TO CLOSE THE TEAR. HOWEVER, THE STAPLER DID NOT FIRE THE STAPLES AND THE DEVICE FELL OUT OF ITS SEATING, CAUSING A FAILURE TO SEAL THE TISSUE. AT 00:15: PT BECAME MORE UNRESPONSIVE W/ V-FIB; CARDIAC MASSAGE AND HEART SHOCKED W/ 15 JOULES X 4 W/ INTERMITTENT HEART MASSAGES. AT 00:49: PT PRONOUNCED. THE SURGEON BELIEVED THAT THE STAPLER MALFUNCTION CONTRIBUTED TOWARD HIS INABILITY TO SAVE THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297835 1 PROXIMATE RELOADABLE LINEAR STAPLER TA STAPLER GDW JOHNSON AND JOHNSON TX60B J4CR6V

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Death