BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDOPATH ETS FLEX

    MDR report key: 288293 · Received August 4, 2000

    Report

    Report Number
    1527736-2000-03555
    Event Type
    Death
    Date Received
    August 4, 2000
    Date of Event
    July 7, 2000
    Report Date
    July 7, 2000
    Manufacturer
    ETHICON ENDO-SURGERY
    Product Code
    KOG
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT (1) DEVICE WAS USED DURING A HEPATECTOMY. IT WAS REPORTED BY THE AFFILIATE THAT AFTER THE FIRST COMPLETED FIRING OF THE ATW35, THE SURGEON THEN RELOADED THE DEVICE WITH A TR35W AND USED IT TO TRANSECT THE HEPATIC VEIN. HOWEVER, WHEN THEY RELEASED THE ANVIL RELEASE BUTTON, A STREAM OF BLOOD WAS COMING OUT. THEY FOUND ONE SIDE OF THE TRIPLE STAGGERED ROWS OF STAPLES, WHICH WAS SUPPOSED TO STAPLE ON THE HEPATIC VEIN, DIDN'T STAPLE AND REMAINED IN THE CARTRIDGE. THE PT LOST MORE THAN 5 LITERS OF BLOOD. THE CASE WAS COMPLETED BY SUTURING. ORIGINAL DEVICE AND RELOAD WERE DISCARDED, BUT TWO UNUSED STERILE DEVICES FROM THE SAME LOT ARE BEING RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ETS FLEX LINEAR CUTTERS-ENDOSCOPIC KOG ETHICON ENDO-SURGERY NA N4HK1T

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death