BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN EGIA SU

    MDR report key: 8347460 · Received February 18, 2019

    Report

    Report Number
    1219930-2019-00936
    Event Type
    Injury
    Date Received
    February 18, 2019
    Date of Event
    August 24, 2017
    Report Date
    February 18, 2019
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE:PROXIMAL LEAKAGE AFTER LAPAROSCOPIC SLEEVE GASTRECTOMY: AN ANALYSIS OF PREOPERATIVE AND OPERATIVE PREDICTORS ON 1738 CONSECUTIVE PROCEDURE. SOURCE: GIOVANNI CESANA, STEFANO CIOFFI, RICCARDO GIORGI. PUBLISHED ONLINE: 24 AUGUST 2017. # SPRINGER SCIENCE+BUSINESS MEDIA, LLC 2017. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE LITERATURE, A RESEARCH STUDY FOR PREDICTIVE FACTORS FOR PROXIMAL LEAKAGE AFTER LAPAROSCOPIC SLEEVE GASTRECTOMY (LSG). ONE THOUSAND SEVEN HUNDRED AND THIRTY-EIGHT PATIENTS (1738), COLLECTED IN A PROSPECTIVELY HELD DATABASE FROM 2008 TO 2016. THE SURGICAL MATERIALS USED WERE STAPLER, CARTRIDGES, AND REINFORCEMENT OF THE SUTURE. PROXIMAL LEAKAGE WAS OBSERVED IN 45 PATIENTS OUT OF 1738. IN THREE PATIENTS, THE LEAKAGE APPEARED AT THE BOTTOM OF THE GASTRIC SUTURE, AND IT WAS RELATED TO A MECHANICAL PROBLEM DURING THE GASTRIC SECTION. IN ALL THREE CASES, THE LEAKAGE WAS MANAGED BY A LAPAROSCOPIC INTERVENTION WITH SUTURE OF THE GASTRIC DEHISCENCE. IN 45 PATIENTS, THE LEAKAGE APPEARED AT THE PROXIMAL PART OF THE GASTRIC SUTURE. ALL PATIENTS WHO DEVELOPED A PROXIMAL LEAKAGE REPORTED ABDOMINAL PAIN AND FEVER AND UNDERWENT BLOOD TESTS SHOWING LEUKOCYTOSIS AND CT SCAN WITH GASTROGRAFIN PER OS SHOWING LEAKAGE. IN 42 PATIENTS, THE LEAKAGE WAS ASSOCIATED WITH AN ABDOMINAL ABSCESS, AND IN 24 CASES THERE WAS EVIDENCE OF FREE INTRA-ABDOMINAL AIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141751 UNKNOWN EGIA SU STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN UNKNOWN ENDO GIA SULU

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other