BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN EEA

    MDR report key: 12084096 · Received June 29, 2021

    Report

    Report Number
    2647580-2021-02186
    Event Type
    Injury
    Date Received
    June 29, 2021
    Date of Event
    February 26, 2020
    Report Date
    June 29, 2021
    Manufacturer
    US SURGICAL PUERTO RICO
    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 SURGICAL OUTCOMES AMONG DIFFERENT METHODS OF ESOPHAGOJEJUNOSTOMY IN LAPAROSCOPIC TOTAL GASTRECTOMY FOR CLINICAL STAGE I PROXIMAL GASTRIC CANCER: RESULTS OF A SINGLE-ARM MULTICENTER PHASE II CLINICAL TRIAL IN KOREA, KLASS 03 SOURCE: SURGICAL ENDOSCOPY (2021) 35:1156¿1163 PUBLISHED ONLINE: 6 MARCH 2020. (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE LITERATURE, (YEAR OCTOBER 2012 AND JANUARY 2014) THIS STUDY AIMED TO ASSESS THE OUTCOME IN PATIENTS WHO UNDERWENT LAPAROSCOPIC TOTAL GASTRECTOMY USING 3 DIFFERENT METHODS OF ESOPHAGOJEJUNOSTOMY. THERE WERE 160 PATIENTS IN THE STUDY: 45 PATIENTS WERE IN THE EXTRACORPOREAL CIRCULAR (EC) STAPLING GROUP, 64 PATIENTS WERE IN THE INTRACORPOREAL (IC) CIRCULAR STAPLING GROUP, AND 51 PATIENTS WERE INCLUDED IN THE INTRACORPOREAL (IL) LINEAR STAPLING GROUP. IN THE IC GROUP, A 21MM CIRCULAR STAPLER WITH OR WITHOUT ORVIL WAS USED IF ESOPHAGUS WAS SMALL. COMPLICATIONS INCLUDED: ESOPHAGOJEJUNOSTOMY (EJ) INSUFFICIENCY, EJ LEAK, EJ STENOSIS AND INTRAABDOMINAL ABSCESS. EJ INSUFFICIENCY WAS TREATED INTRAOPERATIVELY WITH REINFORCEMENT SUTURES. THE ABSCESS AND EJ STENOSIS WERE TREATED WITH SURGICAL DRAINAGE AND ENDOSCOPIC INTERVENTIONS. REOPERATIONS AND READMISSIONS WERE REPORTED BUT REOPERATIONS WERE NOT DEVICE RELATED. COMPLICATIONS IN THE IL GROUP WERE NOT RELATED TO THE DEVICE, AS THE DEVICE BRAND WAS NOT SPECIFIED. COMPARISON OF SURGICAL OUTCOMES AMONG DIFFERENT METHODS OF ESOPHAGOJEJUNOSTOMY IN LAPAROSCOPIC TOTAL GASTRECTOMY FOR CLINICAL STAGE I PROXIMAL GASTRIC CANCER: RESULTS OF A SINGLE-ARM MULTICENTER PHASE II CLINICAL TRIAL IN KOREA, KLASS 03 / HAN-KWANG YANG1 · WOO J IN HYUNG2 · SANG-UK HAN3 · YOUNG-JUN LEE4 · JOONG-MIN PARK5 · GYU SEOK CHO6 · OH KYOUNG KWON7 · SEONG-HO KONG1 · HYOUNG-IL KIM2 · HYUK-JOON LEE1 · WOOK KIM8 · SEUNG WAN RYU9 · SUNG-HO JIN10 · SUNG JIN OH11 · KEUN WON RYU12 · MIN-CHAN KIM13 · HYE SEONG AHN14 · YOUN G KYU PARK15 ·YONG HO KIM16 · SUN-HWI HWANG17 · JONG WON KIM5 · JIN-JO KIM18 / RECEIVED: 22 NOVEMBER 2019 / ACCEPTED: 26 FEBRUARY 2020 / PUBLISHED ONLINE: 6 MARCH 2020 / SPRINGER SCIENCE+BUSINESS MEDIA, LLC, PART OF SPRINGER NATURE 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    985258 UNKNOWN EEA STAPLE, IMPLANTABLE GDW US SURGICAL PUERTO RICO UNKNOWN EEA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R