BEUDAMED
    FDA Adverse Event Death Summary report: N

    ETS-FLEX - ENDOSCOPIC ARTICULATING LINEAR CUTTER (VASCULAR/THIN) - 35 MM

    MDR report key: 870409 · Received June 25, 2007

    Report

    Report Number
    1527736-2007-04351
    Event Type
    Death
    Date Received
    June 25, 2007
    Date of Event
    June 11, 2007
    Report Date
    June 11, 2007
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO NOT AVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UPPER LEFT LOBECTOMY PROCEDURE, THE DEVICE WAS FIRED 6 TIMES ON VESSELS 3-4 MM IN SIZE. AFTER THOROUGH INSPECTION AND TESTING OF ALL STAPLE LINES (SURGEON PERFORMED APPROX 15 MINUTE LYMPHADENECTOMY AFTER THE RESECTION), THE PT HAD EMERGENT BLOOD LOSS THROUGH THE CHEST TUBE WHILE WAITING IN THE ICU 45-60 MINUTES POST STAPLE FIRINGS. THEY OPENED PT AND THERE WAS BLEEDING THROUGHOUT THE CAVITY. PT LOST APPROX 800CC. RESECTED THE ENTIRE LUNG IN AN EFFORT TO FIND THE SOURCE OF THE BLEEDING. THE PT EXPIRED AFTERWARDS. NO AUTOPSY WILL BE PERFORMED DUE TO ORTHODOX BELIEFS OF THE PT AND FAMILY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETS-FLEX - ENDOSCOPIC ARTICULATING LINEAR CUTTER (VASCULAR/THIN) - 35 MM GDW ETHICON ENDO-SURGERY, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death