BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN LIGASURE INSTRUMENT

    MDR report key: 10714732 · Received October 21, 2020

    Report

    Report Number
    1717344-2020-01253
    Event Type
    Injury
    Date Received
    October 21, 2020
    Date of Event
    December 16, 2019
    Report Date
    October 21, 2020
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TITLE: USE OF THE GASTRODUODENAL ARTERY IN HEPATIC ARTERY RECONSTRUCTION FOR IATROGENIC HEPATIC ARTERY INJURY DURING LAPAROSCOPIC TOTAL GASTRECTOMY: CASE REPORT AND REVIEW OF THE LITERATURE SOURCE: ANN VASC SURG 2020; 66: 666.E1¿666.E5 PUBLISHED ONLINE: 2 JANUARY 2020. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO A LITERATURE STUDY OF A WOMAN WHO UNDERWENT AN ELECTIVE LAPAROSCOPIC TOTAL GASTRECTOMY. LIGASURE WAS USED TO LIGATE THE SHORT GASTRIC ARTERIES. WHEN LIGATED BLEEDING WAS NOTED AND THE SOURCE WAS FOUND TO BE INADVERTENT RESECTION OF THE HEPATIC ARTERY. THE PROCEDURE WAS CONVERTED TO OPEN AND RECONSTRUCTION OF THE HEPATIC ARTERY WAS PERFORMED. ESTIMATED BLOOD LOSS WAS 500ML. NO POST-OPERATIVE COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1175607 UNKNOWN LIGASURE INSTRUMENT ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN MFG DC BOULDER UNKNOWN LIGASURE INSTRUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention