BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN EEA

    MDR report key: 12696032 · Received October 26, 2021

    Report

    Report Number
    2647580-2021-03622
    Event Type
    Injury
    Date Received
    October 26, 2021
    Date of Event
    August 19, 2021
    Report Date
    October 26, 2021
    Manufacturer
    US SURGICAL PUERTO RICO
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: GASTROJEJUNAL ANASTOMOTIC STRICTURE FOLLOWING ROUX-EN-Y GASTRIC BYPASS: AN ANALYSIS OF ANASTOMOTIC TECHNIQUE AT A SINGLE INSTITUTION SOURCE: ARTICLE: ABDELRAHMAN NIMERI, 2021, OBESITY SURGERY (2021) 31:4947¿4952, HTTPS://DOI.ORG/10.1007/S11695-021-05678-2. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO A LITERATURE SOURCE OF STUDY PERFORMED BETWEEN JANUARY 2010 AND DECEMBER 2014, WHICH WAS A RETROSPECTIVE STUDY COMPARED THREE DIFFERENT ANASTOMOTIC TECHNIQUES FOR CREATING THE GASTROJEJUNAL ANASTOMOSIS (GJA) IN PATIENTS UNDERGOING LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS, THE THREE TECHNIQUES WERE THE CIRCULAR STAPLED, THE LINEAR STAPLED AND THE ROBOTIC HAND SEWN. A 25MM CIRCULAR STAPLER WAS USED IN THE CIRCULAR STAPLED GROUP. THE COMPANY DEVICES WERE NOT USED IN THE OTHER TWO GROUPS. THERE WERE 652 PATIENTS IN THE CIRCULAR STAPLED GROUP AND COMPLICATIONS INCLUDED: GJA STRICTURE (32 PATIENTS), GJA PERFORATION, AND BLEEDING. ALL PATIENTS WITH STRICTURE UNDERWENT ENDOSCOPIC DILATION. REOPERATION WAS REQUIRED FOR GJA REVISION AND SECONDARY TO STRICTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1594604 UNKNOWN EEA STAPLE, IMPLANTABLE GDW US SURGICAL PUERTO RICO UNKNOWN EEA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention