BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ENDO GIA SULU

    MDR report key: 12636173 · Received October 14, 2021

    Report

    Report Number
    1219930-2021-04258
    Event Type
    Injury
    Date Received
    October 14, 2021
    Date of Event
    May 26, 2021
    Report Date
    October 14, 2021
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: EARLY OUTCOMES AND MID-TERM SAFETY OF ONE ANASTOMOSIS GASTRIC BYPASS ARE COMPARABLE WITH ROUX-EN-Y GASTRIC BYPASS: A SINGLE CENTER EXPERIENCE SOURCE: RECEIVED: 2 JANUARY 2021 / REVISED: 24 MAY 2021 /ACCEPTED: 26 MAY 2021 # THE AUTHOR(S), UNDER EXCLUSIVE LICENCE TO SPRINGER SCIENCE+BUSINESS MEDIA, LLC, PART OF SPRINGER NATURE 2021 OBESITY SURGERY (2021) 31:3786¿3792 HTTPS://DOI.ORG/10.1007/S11695-021-05508-5. 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 FEBRUARY 2012 AND DECEMBER 2018, WHICH WAS A RETROSPECTIVE STUDY THAT COMPARED THE RESULTS OF PATIENTS UNDERGOING ONE ANASTOMOSIS GASTRIC BYPASS (OAGB) AND ROUX-EN-Y GASTRIC BYPASS (RYGB), ALL PROCEDURES WERE PERFORMED LAPAROSCOPICALLY. IT WAS NOTED THERE WERE 314 PATIENTS; 132 UNDERWENT PRIMARY LAPAROSCOPIC RYGB AND 182 HAD OAGB. A TRI-STAPLER WITH PURPLE OR TAN RELOADS AND A STAPLER FROM A DIFFERENT MANUFACTURER WERE USED FOR THE GASTRIC POUCH, THE GASTRO-JEJUNOSTOMY ANASTOMOSIS AND THE JEJUNO-JEJUNOSTOMY ANASTOMOSIS. COMPLICATIONS INCLUDED: BLEEDING AND MARGINAL ULCER. ONE PATIENT WITH BLEEDING REQUIRED REOPERATION. TWO PATIENTS WITH PERFORATED MARGINAL ULCER REQUIRED REOPERATION. THE AVERAGE LENGTH OF HOSPITAL STAY FOR THE RYGB GROUP WAS 3.58 DAYS AND 4.06 DAYS FOR THE OAGB BATCH. NO OTHER COMPLICATIONS WERE RELATED TO THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1528840 UNKNOWN ENDO GIA SULU STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN UNKNOWN ENDO GIA SULU

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization| R