BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN LIGASURE INSTRUMENT

    MDR report key: 11186364 · Received January 18, 2021

    Report

    Report Number
    2647580-2021-00233
    Event Type
    Injury
    Date Received
    January 18, 2021
    Date of Event
    February 25, 2018
    Report Date
    January 18, 2021
    Manufacturer
    US SURGICAL PUERTO RICO
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: PURE LAPAROSCOPIC LIVING DONOR LEFT LATERAL SECTIONECTOMY IN PEDIATRIC TRANSPLANTATION: A PROPENSITY SCORE ANALYSIS ON 220 CONSECUTIVE PATIENTS SOURCE: LIVER TRANSPLANTATION 24 1019 1030 2018 AASLD. RECEIVED JANUARY 1, 2018; ACCEPTED FEBRUARY 25, 2018. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE LITERATURE SOURCE, A STUDY COMPARED OUTCOMES FOR PATIENTS WHO UNDERWENT LIVING DONOR OPEN LEFT LATERAL SECTIONECTOMY AND LAPAROSCOPIC LEFT LATERAL SECTIONECTOMY BETWEEN JANUARY 2011 AND APRIL 2017. THERE WERE 220 PATIENTS, 141 PATIENTS UNDERWENT OPEN PROCEDURE, AND 79 UNDERWENT LAPAROSCOPIC PROCEDURE. LIGASURE WAS USED TO DIVIDE THE FALCIFORM AND THE LEFT TRIANGULAR LIGAMENTS. POST-OPERATIVE COMPLICATIONS INCLUDE: BLOOD LOSS UP TO 800ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84694 UNKNOWN LIGASURE INSTRUMENT ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI US SURGICAL PUERTO RICO UNKNOWN LIGASURE INSTRUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R