BEUDAMED
    FDA Adverse Event Death Summary report: N

    TA PREMIUM 55-4.8 TITANIUM DLU

    MDR report key: 472415 · Received July 18, 2003

    Report

    Report Number
    2647580-2003-00149
    Event Type
    Death
    Date Received
    July 18, 2003
    Date of Event
    March 5, 2003
    Report Date
    July 14, 2003
    Manufacturer
    PONCE - USS
    Product Code
    GAG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING THE COMPLETION OF THE UPPER LOBECTOMY, WHEN THE DEVICE WAS PLACED ON THE TISSUE, THE SURGEONS QUESTIONED THE ALIGNMENT OF THE DEVICE. THEY HOPED THEY COULD OVERSEW AND CONTINUED WITH THE FIRING. THEY STRUCK THE PULMONARY ARTERY AND WERE UNABLE TO CONTROL THE BLEEDING, THE PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TA PREMIUM 55-4.8 TITANIUM DLU DISPOSABLE LOADING UNIT GAG PONCE - USS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death