BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ENDO GIA SULU

    MDR report key: 10598914 · Received September 29, 2020

    Report

    Report Number
    1219930-2020-04017
    Event Type
    Injury
    Date Received
    September 29, 2020
    Date of Event
    July 31, 2020
    Report Date
    September 29, 2020
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: COMPARISON OF THE CLINICAL OUTCOMES BETWEEN ISOPERISTALTIC AND ANTIPERISTALTIC ANASTOMOSES AFTER LAPAROSCOPIC DISTAL GASTRECTOMY FOR PATIENTS WITH GASTRIC CANCER SOURCE: FRONT. ONCOL., VOLUME 10, ARTICLE 1237 PUBLISHED: JULY 31, 2020. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE LITERATURE REPORT, THE STUDY AIMED TO COMPARE THE CLINICAL OUTCOMES BETWEEN ISOPERISTALTIC AND ANTIPERISTALTIC ANASTOMOSES AFTER TOTAL LAPAROSCOPIC DISTAL GASTRECTOMY IN PATIENTS WITH GASTRIC CANCER. POST-OPERATIVELY, IT WAS REPORTED THAT TWO PATIENTS HAD INTRA-ABDOMINAL ABSCESS, ONE PATIENT HAD ANASTOMOTIC LEAKAGE, AND ONE PATIENT HAD DUODENAL STUMP LEAKAGE. TITLE OF THE ARTICLE: COMPARISON OF THE CLINICAL OUTCOMES BETWEEN ISOPERISTALTIC AND ANTIPERISTALTIC ANASTOMOSES AFTER LAPAROSCOPIC DISTAL GASTRECTOMY FOR PATIENTS WITH GASTRIC CANCER AUTHORS: YOONTAEK LEE, CHANG MIN LEE, SUNGSOO PARK, JONG-HAN KIM AND SEONG-HEUM PARK YEAR: 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1063644 UNKNOWN ENDO GIA SULU STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN UNKNOWN ENDO GIA SULU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other