BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA ORVIL

    MDR report key: 8420101 · Received March 14, 2019

    Report

    Report Number
    1219930-2019-01514
    Event Type
    Injury
    Date Received
    March 14, 2019
    Date of Event
    April 23, 2014
    Report Date
    March 14, 2019
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    UDI-DI
    20884521042862
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TITLE: "MINIMALLY INVASIVE OESOPHAGECTOMY: PRELIMINARY RESULTS AFTER INTRODUCTION OF AN INTRATHORACIC ANASTOMOSIS." SOURCE: DIGESTIVE SURGICAL, 2014 (95-103). DATE OF PUBLICATION: 23 APRIL 2014. 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 FROM JANUARY 2011 UNTIL AUGUST 2012, A TOTAL OF 45 OPERABLE PATIENTS WERE SCHEDULED TO UNDERGO MINIMALLY INVASIVE ESOPHAGECTOMY (MIE) WITH INTRATHORACIC ANASTOMOSIS. NINE OF THE 45 PATIENTS WERE UNDER GROUP 1 WHEREIN A CIRCULAR STAPLER WITH AN ORAL ANVIL WAS USED TO CREATE THE INTRATHORACIC ANASTOMOSIS. FOUR OF THE NINE PATIENTS HAD AN ANASTOMOTIC LEAK AND UNDERWENT RE-OPERATION WHILE ONE PATIENT WAS RE-ADMITTED TO THE HOSPITAL. SIX PATIENTS HAD DEVELOPED PULMONARY COMPLICATIONS; FIVE PATIENTS DEVELOPED CARDIAC COMPLICATIONS AND THREE PATIENTS WERE READMITTED TO THE ICU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214205 EEA ORVIL STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN EEAORVIL25 20884521042862

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| L| R