BEUDAMED
    FDA Adverse Event Death Summary report: N

    ETHICON

    MDR report key: 7167215 · Received December 28, 2017

    Report

    Report Number
    7167215
    Event Type
    Death
    Date Received
    December 28, 2017
    Date of Event
    November 8, 2017
    Report Date
    November 30, 2017
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GAG
    UDI-DI
    10705036015352
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS ADMITTED ON (B)(6) 2017 FOR ELECTIVE SURGERY WITH GENERAL SURGERY SERVICE FOR A LIVER TUMOR. THE SURGERY HAD NO COMPLICATIONS UNTIL A STAPLE DEVICE WAS USED TO PROVIDE A CUT TO AN ISOLATED AREA TO REMOVE THE REMAINING TUMOR IN THE LIVER. THERE WAS A MISFIRING AND MALFUNCTION OF THE DEVICE WHICH CAUSED A HOLE IN A LARGE VESSEL CLOSE TO THE HEART THAT RESULTED IN INTRAOPERATIVE HEMORRHAGE, SHOCK, CARDIAC ARREST AND UNEXPECTED DEATH DESPITE MULTIPLE EFFORTS TO CONTROL THE BLEEDING. REPORTER'S COMPLETE EMAIL (NOT ENOUGH SPACE ON PAGE 1 TO PROVIDE COMPLETE EMAIL): (B)(6). SENDING UPDATE TODAY TO INFORM THAT THE REPRESENTATIVE FROM THE (B)(4) LOCATION PICKED UP THE SEQUESTERED DEVICE ON (B)(4) 2017 IN ORDER FOR THE MANUFACTURER TO RUN THE DEVICE THROUGH QUALITY CONTROL TO DETERMINE WHY DEVICE MAY HAVE MALFUNCTIONED. REPORT OF FINDINGS TO BE PROVIDED TO MEDICAL CENTER IN APPROXIMATELY 45 DAYS FROM DATE OF PICK UP FROM (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    932758 ETHICON ECHELON FLEX POWERED PLUS STAPLER GAG ETHICON ENDO-SURGERY, LLC P91L4K 10705036015352

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death| L| R BATCH NUMBER ON RELOAD (STAPLERS) 956M3F.| OTHER IDENTIFYING NUMBERS ON THIS EQUIPMENT: A000441P00, (B)(4) .| STAPLER BATCH #P55J7E.