BEUDAMED
    FDA Adverse Event Death Summary report: N

    COVIDIEN SIGNIA STAPLER #1

    MDR report key: 11342090 · Received February 17, 2021

    Report

    Report Number
    MW5099434
    Event Type
    Death
    Date Received
    February 17, 2021
    Date of Event
    February 5, 2021
    Report Date
    February 12, 2021
    Manufacturer
    MEDTRONIC / COVIDIEN
    Product Code
    GDW
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT HAD PNEUMONECTOMY, SURGERY WENT WELL. AFTER CLOSING, WHILE MOVING PATIENT TO STRETCHER, SUDDEN DROP IN BP, SURGEON RE-OPENED PATIENT AND FOUND MASSIVE BLEEDING IN CHEST. BLOOD FROM PULMONARY ARTERY AT SITE WHERE STAPLES HAD BEEN PLACED, BUT THEY WERE NO LONGER PRESENT. UNABLE TO RESCUE. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237613 COVIDIEN SIGNIA STAPLER #1 STAPLE, IMPLANTABLE GDW MEDTRONIC / COVIDIEN SIG30CTAV N8H0468X

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Death PROGEL