BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN EGIA TRI STAPLE

    MDR report key: 10289357 · Received July 17, 2020

    Report

    Report Number
    1219930-2020-02851
    Event Type
    Injury
    Date Received
    July 17, 2020
    Date of Event
    November 1, 2019
    Report Date
    July 17, 2020
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TITLE: ABSTRACTS OF THE ASSOCIATION OF UPPER GASTROINTESTINAL SURGEONS OF GREAT BRITAIN AND IRELAND SOURCE: BJS 2019; 106 (S7): 5¿94 AUGIS ABSTRACTS 2019. 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 TO MAY 2019, 74 CONSECUTIVE PATIENTS WAS UNDERGOING OESOPHAGECTOMY FOR CANCER BY A SINGLE SURGEON. THE OESOPHAGO-GASTRIC ANASTOMOSIS USED A RELOAD FOLLOWED BY A TWO-LAYERED CLOSURE WITH CONTINUOUS SUTURE, INITIALLY A SUTURE BUT MORE RECENTLY A BARBED SUTURE. THE HYBRID APPROACH (LAPAROSCOPIC GASTRIC MOBILISATION FOLLOWED BY RIGHT THORACOTOMY) WAS INITIALLY UTILIZED IN THE FIRST 47 PATIENTS. SINCE APRIL 2018, ALL PATIENTS UNDERWENT A COMPLETE MINIMALLY INVASIVE OESOPHAGECTOMY (MIO). ADVERSE EVENTS WERE NOTED; ONE PATIENT DEVELOPED A TYPE III CONDUIT NECROSIS REQUIRING OESOPHAGOSTOMY AFTER THE HYBRID APPROACH. FIFTEEN PATIENTS DEVELOPED ANASTOMOTIC STRICTURES REQUIRING A MEDIAN OF ONE DILATATION. FIFTY PERCENT OF PATIENTS WHO HAD ANASTOMOTIC LEAKS DEVELOPED STRICTURES (2/4). THE MEDIAN LENGTH OF STAY WAS 10 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752778 UNKNOWN EGIA TRI STAPLE STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN UNKNOWN EGIA TRI STAPLE

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention