BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ETS FLEX ARTICNG LNR CUTR 45MM

    MDR report key: 6990283 · Received October 31, 2017

    Report

    Report Number
    3005075853-2017-05801
    Event Type
    Malfunction
    Date Received
    October 31, 2017
    Report Date
    October 3, 2017
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS A LOT/BATCH WAS NOT PROVIDED, A DEVICE HISTORY COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA 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 CONSEQUENCS. 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
    770718 ENDOPATH ETS FLEX ARTICNG LNR CUTR 45MM STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR