BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN EEA

    MDR report key: 8420178 · Received March 14, 2019

    Report

    Report Number
    2647580-2019-01372
    Event Type
    Injury
    Date Received
    March 14, 2019
    Date of Event
    April 23, 2014
    Report Date
    March 14, 2019
    Manufacturer
    US SURGICAL PUERTO RICO
    Product Code
    GDW
    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
    215836 UNKNOWN EEA STAPLE, IMPLANTABLE GDW US SURGICAL PUERTO RICO UNKNOWN EEA

    Patients

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