BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN EEA

    MDR report key: 11626869 · Received April 7, 2021

    Report

    Report Number
    1219930-2021-01406
    Event Type
    Death
    Date Received
    April 7, 2021
    Date of Event
    February 1, 2021
    Report Date
    April 7, 2021
    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 HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: ANALYSIS OF OUTCOMES OF A TRANSORAL CIRCULAR STAPLED ANASTOMOSIS FOLLOWING MAJOR UPPER GASTROINTESTINAL CANCER RESECTION. SOURCE: DISEASES OF THE ESOPHAGUS (2021)00, 1¿8. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE LITERATURE, A STUDY ANALYZED THE OUTCOMES OF PATIENTS WHO UNDERWENT ESOPHAGECTOMY (OPEN OR LAPAROSCOPICALLY ASSISTED TRANSTHORACIC) AND GASTRECTOMY USING THE ORVIL ANASTOMOTIC DEVICE BETWEEN 2011 AND 2019. THERE WERE 227 ESOPHAGECTOMIES AND 101 GASTRECTOMIES PERFORMED. THE ANASTOMOSES WERE COMPLETED WITH A 25 MM CIRCULAR STAPLER WITH A 4.8 MM STAPLE HEIGHT. COMPLICATIONS INCLUDED TWO (2) DEATHS IN THE LEAK GROUP DUE TO MULTI-ORGAN FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526680 UNKNOWN EEA STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN UNKNOWN EEA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death