BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN LIGASURE INSTRUMENT

    MDR report key: 12104173 · Received July 1, 2021

    Report

    Report Number
    1717344-2021-00927
    Event Type
    Injury
    Date Received
    July 1, 2021
    Date of Event
    April 11, 2021
    Report Date
    July 1, 2021
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: LITTORAL CELL ANGIOMA OF THE SPLEEN IN A CHILD WITH CORNELIA DE LANGE SYNDROME SOURCE: JOURNAL OF PEDIATRIC SURGERY CASE REPORTS 69 (2021) 101868 AVAILABLE ONLINE 21 APRIL 2021. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE LITERATURE SOURCE STUDY PERFORMED ON APRIL 11, 2021. A (B)(6) FEMALE UNDERWENT LAPAROSCOPIC SPLENECTOMY FOR MULTIPLE CYSTS IN THE SPLEEN AND SPLENOMEGALY DUE TO CORNELIA DE LANGE SYNDROME. LIGASURE WAS USED DURING THE PROCEDURE. COMPLICATIONS INCLUDED INTRAOPERATIVE BLEEDING. CONVERSION TO OPEN PROCEDURE WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    995473 UNKNOWN LIGASURE INSTRUMENT ELECTROSURGICAL, CUTTING & COAGULATION & ACCES GEI COVIDIEN MFG DC BOULDER UNKNOWN LIGASURE INSTRUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Required Intervention