BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN EEA

    MDR report key: 8561089 · Received April 29, 2019

    Report

    Report Number
    2647580-2019-02305
    Event Type
    Injury
    Date Received
    April 29, 2019
    Date of Event
    October 19, 2018
    Report Date
    April 29, 2019
    Manufacturer
    US SURGICAL PUERTO RICO
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ARTICLE: STENOSIS AFTER ESOPHAGOJEJUNOSTOMY WITH THE HEMI-DOUBLE-STAPLING TECHNIQUE USING THE TRANSORALLY INSERTED ANVIL (ORVIL¿) IN ROUX-EN-Y RECONSTRUCTION WITH ITS EFFERENT LOOP LOCATED ON THE PATIENT¿S LEFT SIDE FOLLOWING LAPAROSCOPIC TOTAL GASTRECTOMY AUTHOR: TAKAYA TOKUHARA PUBLICATION: SPRINGER SCIENCE+BUSINESS MEDIA, LLC, PART OF SPRINGER NATURE 2018. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. [(B)(4)].

    Description of Event or Problem · 1

    ACCORDING TO LITERATURE SOURCE OF PERFORMED FROM NOVEMBER 2013 TO DECEMBER 2016, 24 PATIENTS WITH GASTRIC CANCER UNDERWENT INTRACORPOREAL CIRCULAR-STAPLED ESOPHAGOJEJUNOSTOMY WITH THE HEMI-DOUBLE-STAPLING TECHNIQUE USING THE ORVIL IN ANTECOLIC ROUX-EN-Y RECONSTRUCTION. COMPLICATIONS RELATED TO ANASTOMOSIS WERE, 1 PATIENT (4.1%) HAD ANASTOMOTIC LEAKAGE, 2 PATIENTS (8.3%) HAD ANASTOMOTIC STENOSIS, AND 1 PATIENT (4.1%) HAD INTRA ABDOMINAL BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353402 UNKNOWN EEA STAPLE, IMPLANTABLE GDW US SURGICAL PUERTO RICO UNKNOWN EEA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other