BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA

    MDR report key: 8423144 · Received March 14, 2019

    Report

    Report Number
    1219930-2019-01535
    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
    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). (EXTENDED HOSPITAL STAY, RE-OPERATION) TITLE MINIMALLY INVASIVE OESOPHAGECTOMY: PRELIMINARY RESULTS AFTER INTRODUCTION OF AN INTRATHORACIC ANASTOMOSIS SOURCE DIGESTIVE SURGICAL, VOLUME 31, 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, A TOTAL OF 45 OPERABLE PATIENTS WERE SCHEDULED TO UNDERGO MINIMALLY INVASIVE ESOPHAGECTOMY (MIE) WITH INTRATHORACIC ANASTOMOSIS. EIGHTEEN OUT OF THE 45 PATIENTS WERE UNDER GROUP 2 WHEREIN A CIRCULAR STAPLER WAS USED TO CREATE AN INTRATHORACIC ANASTOMOSIS ALONG WITH ITS ANVIL BEING INSERTED THROUGH ONE OF THE PORTS AND SECURED WITH 2 PURSE STRINGS USING THE STITCHING DEVICE AND SUTURE. EIGHT PATIENTS DEVELOPED PULMONARY COMPLICATIONS AND 5 PATIENTS DEVELOPED CARDIAC COMPLICATIONS. THREE PATIENTS WERE RE-OPERATED, FOUR PATIENTS WERE RE-ADMITTED TO THE INTENSIVE CARE UNIT (ICU) AND THREE WERE RE-ADMITTED TO THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215017 EEA STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN EEA28

    Patients

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