BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN LIGASURE INSTRUMENT

    MDR report key: 14318144 · Received May 7, 2022

    Report

    Report Number
    1717344-2022-00554
    Event Type
    Injury
    Date Received
    May 7, 2022
    Date of Event
    March 25, 2021
    Report Date
    May 6, 2022
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    TITLE: RELATIONSHIP BETWEEN HEPATIC VENOUS ANATOMY AND HEPATIC VENOUS BLOOD LOSS DURING HEPATECTOMY SOURCE: SURGERY TODAY (2021) 51:1953¿1968 HTTPS://DOI.ORG/10.1007/S00595-021-02314-5. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ACCORDING TO THE LITERATURE, A RETROSPECTIVE STUDY ANALYZED OUTCOMES OF PATIENTS WITH HEPATOBILIARY DISEASE WHO UNDERWENT OPEN HEPATECTOMY BETWEEN APRIL 2014 AND MARCH 2020. THE STUDY POPULATION INCLUDED 63 PATIENTS WITH HEPATOBILIARY DISEASES WHO WERE SCHEDULED FOR SURGERY AND WHO WERE ADMITTED TO ONE OF THE TWO INSTITUTIONS. LIGASURE WAS ONE DEVICE USED FOR HEMOSTASIS. THE DEVICE HAD AN AUTOMATIC CUTTING FUNCTION DURING COAGULATION. AGAIN, THE SEALING TIME WAS A FEW SECONDS. SEALED VESSELS WERE CUT USING FINE SCISSORS. ANY BLEEDING SITES OR MACROSCOPICALLY DETECTED BILE LEAKAGE POINTS IN THE CUT PLANE WERE SUTURED. INFRA-HEPATIC INFERIOR VENA CAVA - RIGHT ATRIUM (IVC-RA) GAP INCREASED INTRAOPERATIVE BLOOD LOSS OF 950 ML LEADING TO BLOOD TRANSFUSION IN 18 PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1294973 UNKNOWN LIGASURE INSTRUMENT ELECTROSURGICAL, CUTTING & COAGULATION & ACCES GEI COVIDIEN MFG DC BOULDER UNKNOWN LIGASURE INSTRUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Other