BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ENDO GIA SULU

    MDR report key: 11606728 · Received April 2, 2021

    Report

    Report Number
    1219930-2021-01352
    Event Type
    Injury
    Date Received
    April 2, 2021
    Date of Event
    August 29, 2020
    Report Date
    April 2, 2021
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: EFFECTIVENESS AND POSTOPERATIVE PAIN LEVEL OF SINGLE-PORT VERSUS TWO-PORT THORACOSCOPIC LOBECTOMY FOR LUNG CANCER: A RETROSPECTIVE COHORT STUDY SOURCE: GENERAL THORACIC AND CARDIOVASCULAR SURGERY (2021) 69:318¿325. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED BETWEEN OCTOBER 2014 AND OCTOBER 2017, POSTOPERATIVE TO SINGLE-PORT THORACOSCOPIC LOBECTOMY AND TWO-PORT THORACOSCOPIC LOBECTOMY, COMPLICATIONS SUCH AS INCLUDED BLEEDING, PULMONARY AIR LEAK AND BRONCHOPLEURAL FISTULA WERE OBSERVED. REOPERATION WAS PERFORMED DUE TO BLEEDING. SURGERY WAS CONVERTED TO OPEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508760 UNKNOWN ENDO GIA SULU STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN UNKNOWN ENDO GIA SULU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention