BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPATH

    MDR report key: 6988579 · Received October 30, 2017

    Report

    Report Number
    3005075853-2017-05787
    Event Type
    Injury
    Date Received
    October 30, 2017
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WE DID NOT RECEIVE A BATCH OR LOT NUMBER FOR THE PRODUCT INVOLVED IN THIS COMPLAINT. THEREFORE, WE WERE UNABLE TO CHECK MANUFACTURING RECORDS FOR ANY RELATED NON-CONFORMANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING REVIEW OF JOURNAL ARTICLE: DANGERS IN THE USE OF STAPLERS IN LIVER SURGERY. AUTHORS: ANGELA RIGA, NARIMAN KARANJIA. CITATION: ANN R COLL SURG ENGL 2007; 89: 810¿811. THE AUTHORS REPORT 2 CASES WHERE THE ENDOPATH ETS FLEX 45 ENDOSCOPIC ARTICULATING LINEAR CUTTER FAILED WITH DANGEROUS CONSEQUENCES. THE FIRST CASE WAS A (B)(6) WOMAN WITH A COLORECTAL METASTASIS STRADDLING SEGMENTS 2 AND 4A UNDERWENT A LEFT HEMIHEPATECTOMY. AFTER DIVISION OF THE HILAR STRUCTURES AND COMPLETION OF THE PARENCHYMAL TRANSECTION, THE LEFT MIDDLE VEIN COMPLEX WAS STAPLED WITH ENDOPATH ETS FLEX 45 ENDOSCOPIC ARTICULATING LINEAR CUTTER. THE STAPLER FIRED STAPLES WHICH DID NOT CLOSE AND THE VEIN WAS DIVIDED WITH CATASTROPHIC BLEEDING. THE HAEMORRHAGE WAS CONTROLLED WITH DIGITAL PRESSURE AND THE OPENING IN THE VENA CAVA UNDER-RUN WITH PROLENE. THE BLOOD LOSS WAS 1000ML, BUT TRANSFUSION WAS AVOIDED AND SHE MADE A FULL RECOVERY. THE 2ND CASE INVOLVED A (B)(6) MAN WITH A COLORECTAL METASTASIS STRADDLING SEGMENTS 4A, 8 AND 7 UNDERWENT A RIGHT HEMI-HEPATECTOMY EXTENDED TO SEGMENT 4A. AFTER EXPOSING AND TAPING THE RIGHT ANTERIOR AND POSTERIOR SECTION TRUNKS, THE ANTERIOR SECTION TRUNK WAS STAPLED WITH ENDOPATH ETS FLEX 45 ENDOSCOPIC ARTICULATING LINEAR CUTTER. THE STAPLER DIVIDED THE TRUNK WITHOUT A ROW OF STAPLES ON THE PROXIMAL END LEADING TO PROFUSE BLEEDING. THE ENSUING HAEMORRHAGE WAS CONTROLLED WITH PRESSURE AND THE ANTERIOR SECTION TRUNK WAS OVERSEWN WITH A PROLENE WHIP STITCH. THE TOTAL OPERATIVE BLOOD LOSS IN THIS PATIENT WAS 2L AND HE REQUIRED A 4-UNIT BLOOD TRANSFUSION, BUT HE MADE A FULL RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765607 ENDOPATH STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention