BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN LIGASURE INSTRUMENT

    MDR report key: 10767475 · Received October 31, 2020

    Report

    Report Number
    1717344-2020-01339
    Event Type
    Injury
    Date Received
    October 31, 2020
    Date of Event
    February 27, 2017
    Report Date
    October 31, 2020
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: SURGICAL OUTCOMES OF LAPAROSCOPIC VERSUS OPEN LIVER RESECTION FOR HEPATOCELLULAR CARCINOMA FOR VARIOUS RESECTION EXTENT SOURCE: CHEN ET AL. MEDICINE (2017) 96:12 MEDICINE (2017) 96:12(E6460) RECEIVED: 4 JANUARY 2017 / RECEIVED IN FINAL FORM: 27 FEBRUARY 2017 / ACCEPTED: 27 FEBRUARY 2017 HTTP://DX.DOI.ORG/10.1097/MD.0000000000006460. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED BETWEEN APRIL 2015 AND SEPTEMBER 2016, THE SURGICAL OUTCOMES (SAFETY AND EFFICACY) OF LAPAROSCOPIC LIVER RESECTIONS (LRRS) VERSUS OPEN LIVER RESECTION (OLR) FOR HEPATOCELLULAR CARCINOMA (HCC) WERE ANALYZED AND RETROSPECTIVELY INVESTIGATED THE DEMOGRAPHIC AND PERIOPERATIVE DATA, AND ALSO SURGICAL OUTCOMES. LAPAROSCOPIC LIVER RESECTION WAS PERFORMED IN 225 PATIENTS AND OLR IN 291. A CAVITRON ULTRASONIC SURGICAL ASPIRATOR (CUSA EXCEL, VALLEYLAB, CO) WAS USED IN THE OPEN PROCEDURE AND BOTH A CUSA AND LIGASURE 5MM BLUNTTIP WAS USED IN THE LAPAROSCOPIC PROCEDURE. THREE PATIENTS IN THE LLR GROUP AND 19 PATIENTS IN THE OLR GROUP REQUIRED BLOOD TRANSFUSION. HEMORRHAGE WAS RECORDED IN 2 LLR PATIENTS AND 4 OLR PATIENTS. WOUND INFECTION WAS RECORDED IN 1 LLR AND 6 OLR PATIENTS. ONE PATIENT IN THE OLR GROUP HAD AN ABDOMINAL ABCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1231909 UNKNOWN LIGASURE INSTRUMENT ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN MFG DC BOULDER UNKNOWN LIGASURE INSTRUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other