BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN LIGASURE INSTRUMENT

    MDR report key: 11167023 · Received January 13, 2021

    Report

    Report Number
    1717344-2021-00056
    Event Type
    Injury
    Date Received
    January 13, 2021
    Date of Event
    November 13, 2020
    Report Date
    January 13, 2021
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: ROBOTIC LOBECTOMY IN CHILDREN WITH SEVERE BRONCHIECTASIS: A WORTHWHILE NEW TECHNOLOGY SOURCE: JOURNAL OF PEDIATRIC SURGERY ACCEPTED 4 NOVEMBER 2020. 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 THE OUTCOMES OF 18 PEDIATRIC PATIENTS WHO UNDERWENT PULMONARY LOBECTOMY FOR SEVERE LOCALIZED BRONCHIECTASIS VIA THORACOSCOPIC (VATS) VERSUS ROBOTIC (RATS) LOBECTOMY BETWEEN 2014 AND 2019. IN 11 VATS PATIENTS, LIGASURE WAS USED FOR DISSECTION OF THE LUNG PARENCHYMA, ADHESIONS AND VESSELS UP TO 7MM. POST-OPERATIVE COMPLICATIONS IN THE VATS PATIENTS WERE: ONE PATIENT WITH A PARENCHYMAL LEAKAGE THAT REQUIRED PERCUTANEOUS DRAINAGE, AND CONVERSION TO OPEN PROCEDURE DUE TO BLEEDING. OTHER COMPLICATIONS NOT RELATED TO THE DEVICE WERE: ONE PATIENT WITH BRONCHIAL FISTULA AND CONVERSION TO OPEN PROCEDURE DUE TO DISSECTION DIFFICULTY. ROBOTIC LOBECTOMY IN CHILDREN WITH SEVERE BRONCHIECTASIS: A WORTHWHILE NEW TECHNOLOGY, MARION DURANDA, LAYLA MUSLEHB, FABRIZIO VATTAC,D, GIORGIA OROFINO, STEFANIA QUERCIAGROSSA, MYRIAM JUGIEF, OLIVIER BUSTARRETF CHRISTOPHE DELACOURT, SABINE SARNACKI, THOMAS BLANCC, NAZIHA KHEN-DUNLOPC, ELSEVIER INC. 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60407 UNKNOWN LIGASURE INSTRUMENT ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN MFG DC BOULDER UNKNOWN LIGASURE INSTRUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention