BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN EGIA TRI STAPLE

    MDR report key: 11924543 · Received June 2, 2021

    Report

    Report Number
    1219930-2021-02178
    Event Type
    Injury
    Date Received
    June 2, 2021
    Date of Event
    December 29, 2020
    Report Date
    June 2, 2021
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: COMPUTED TOMOGRAPHY ASSESSMENT OF FAT DISTRIBUTION AND STAPLE-LINE LEAK RISK AFTER SLEEVE GASTRECTOMY SOURCE: HTTPS://DOI.ORG/10.1007/S11695-020-05199-4/ PUBLISHED ONLINE: 6 JANUARY 2021 OBESITY SURGERY (2021) 31:2011¿2018 THE AUTHOR(S), UNDER EXCLUSIVE LICENCE TO SPRINGER SCIENCE+BUSINESS MEDIA, LLC PART OF SPRINGER NATURE 2020 RECEIVED: 9 OCTOBER 2020 /REVISED: 22 DECEMBER 2020 /ACCEPTED: 29 DECEMBER 2020 / PUBLISHED ONLINE: 6 JANUARY 2021. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE LITERATURE, (YEAR JANUARY 2015 AND DECEMBER 2015) THIS STUDY AIMED TO ASSESS THE OUTCOME OF A RETROSPECTIVE STUDY ANALYZED THE RESULTS OF PATIENTS WHO UNDERWENT SLEEVE GASTRECTOMY. 60MM, TRISTAPLE, PURPLE RELOAD WAS USED TO TRANSECT THE STOMACH. THERE WERE 377 PATIENTS IN THE STUDY AND COMPLICATIONS INCLUDED: INTRAOPERATIVE BLEEDING AND POSTOPERATIVE GASTRIC LEAK. BLEEDING WAS MANAGED DURING THE PROCEDURE. GASTRIC LEAKS REQUIRED ENDOSCOPIC DRAINAGE OR RE-LAPAROSCOPY FOR ABSCESS DRAINAGE. ONE PATIENT DEVELOPED A FISTULA AND REQUIRED REOPERATION. EXTENDED HOSPITAL STAY WAS REQUIRED FOR PATIENTS WITH GASTRIC LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819443 UNKNOWN EGIA TRI STAPLE STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN UNKNOWN EGIA TRI STAPLE

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization| R