BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDOPATH ATS45

    MDR report key: 1854336 · Received October 4, 2010

    Report

    Report Number
    1854336
    Event Type
    Death
    Date Received
    October 4, 2010
    Date of Event
    September 20, 2010
    Report Date
    September 29, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE: ATTEMPTED LAPAROSCOPIC LEFT RADICAL NEPHRECTOMY. THE MASS WAS IDENTIFIED. THE SURGEON DISSECTED AROUND THE RENAL ARTERY AND RENAL VEIN, AND THEN USED THE ETHICON LAPAROSCOPIC STAPLER WITH A VASCULAR LOAD TO LIGATE AND DIVIDE THE RENAL ARTERY. UPON RELEASING THE STAPLER THE LINEAR STAPLER APPEARED TO CUT BUT DID NOT STAPLE. THE SURGEON HELD PRESSURE ON THE RENAL ARTERY STUMP WITH THE STAPLER WHILE CONVERTING THROUGH A GENEROUS SUBCOSTAL INCISION. A HANDHELD RICHARDSON RETRACTOR WAS USED TO HOLD THE LATERAL PART OF THE INCISION OPEN WHILE THE RENAL MEDIAL TO THE KIDNEY WAS PACKED AND BLOOD PRODUCTS WERE OBTAINED. THE STAPLER APPEARED TO HAVE ENGAGED ABOUT 2-4 UNFORMED STAPLES ON THE MEDIAL ASPECT OF THE RENAL ARTERY STUMP THAT WERE NOT REMOVED WHEN PLACING 3-0 PROLENE ONTO THE RENAL ARTERY STUMP. TWO SCHNIDTS WERE USED TO CONTROL THE PROXIMAL SEVERED RENAL ARTERY STUMP AS WELL AS THE PORTION GOING TO THE KIDNEY. ESTIMATED BLOOD LOSS APPROXIMATELY 5 LITERS REQUIRING TRANSFUSION OF 9 UNITS PACKED RED BLOOD CELLS INTRA-OPERATIVELY, IN ADDITION TO 15 UNITS PACKED RED BLOOD CELLS, 12 UNITS FFP, 4 UNITS PLATELETS AND 3 UNITS OF CRYOPRECIPITATE. THE PATIENT WAS TRANSFERRED TO THE TERTIARY HOSPITAL FOR FURTHER INTERVENTION; ON ARRIVAL SHE WAS DEPENDENT ON HIGH DOSES OF INOTROPES AND VASOPRESSORS, WAS IN FRANK RENAL FAILURE AND WAS SEVERELY ACIDOTIC. THE PATIENT'S CLINICAL PICTURE AND LABORATORIES WORSENED WITH PERSISTENT HYPOTENSION AND DISSEMINATED INTRAVASCULAR COAGULATION (DIC). DESPITE CONTINUED AGGRESSIVE INTERVENTION, THE PATIENT'S CONDITION COULD NOT BE STABILIZED AND THE PATIENT DIED APPROXIMATELY 16 HOURS AFTER TRANSFER. AUTOPSY RESULTS ARE PENDING.HEALTH PROFESSIONAL'S IMPRESSION: STAPLER CUT BUT DID NOT STAPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ATS45 STAPLER, CUTTER, SURGICAL GDW ETHICON ENDO-SURGERY, INC. * *
    2 ENDOPATH STAPLER, RELOAD, SURGICAL GDW ETHICON ENDO-SURGERY, INC. VASCULAR/THIN, WHITE CARTRIDGE G4RU3U

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death