BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN LIGASURE INSTRUMENT

    MDR report key: 11895150 · Received May 27, 2021

    Report

    Report Number
    1717344-2021-00764
    Event Type
    Injury
    Date Received
    May 27, 2021
    Date of Event
    March 5, 2021
    Report Date
    May 27, 2021
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: THE ALEXIS® SYSTEM FOR LAPAROSCOPIC SPLENECTOMY IN PEDIATRIC PATIENTS SOURCE: UPDATES IN SURGERY HTTPS://DOI.ORG/10.1007/S13304-021-01023-5. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE LITERATURE, A STUDY ANALYZED OUTCOMES OF PEDIATRIC PATIENTS (AGE 8-17) WHO UNDERWENT LAPAROSCOPIC SPLENECTOMY BETWEEN 2015 AND 2019. LIGASURE WAS USED FOR VESSEL DIVISION. THERE WERE 7 PATIENTS IN THE STUDY AND COMPLICATIONS INCLUDED BLEEDING. ONE PATIENT REQUIRED AN INTRAOPERATIVE BLOOD TRANSFUSION OF 300 ML AND ONE PATIENT UNDERWENT EMBOLIZATION ON THE 4TH POST-OPERATIVE DAY FOR PERSISTENT BLEEDING. HOSPITAL STAY WAS EXTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794636 UNKNOWN LIGASURE INSTRUMENT ELECTROSURGICAL, CUTTING & COAGULATION & ACCES GEI COVIDIEN MFG DC BOULDER UNKNOWN LIGASURE INSTRUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Hospitalization| R