BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ENDO GIA SULU

    MDR report key: 14194509 · Received April 25, 2022

    Report

    Report Number
    1219930-2022-01469
    Event Type
    Injury
    Date Received
    April 25, 2022
    Date of Event
    December 4, 2021
    Report Date
    April 25, 2022
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    TITLE: GASTRIC REMNANT MUCOCELE AFTER CONVERSION OF VERTICAL BAND GASTROPLASTY TO ONE ANASTOMOSIS GASTRIC BYPASS: A VIDEO VIGNETTE SOURCE: OBESITY SURGERY (2022) 32:955¿956, RECEIVED: 14 SEPTEMBER 2021 / REVISED: 9 NOVEMBER 2021 / ACCEPTED: (B)(6) 2021 © THE AUTHOR(S), UNDER EXCLUSIVE LICENCE TO SPRINGER SCIENCE+BUSINESS MEDIA, LLC, PART OF SPRINGER NATURE 2021. HTTPS://DOI.ORG/10.1007/S11695-021-05842-8. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED ON A (B)(6) FEMALE WITH A HISTORY OF VENOUS BLOOD GAS (VBG) FOR MORBID OBESITY, TWO (2) YEARS BEFORE AND BACKGROUND OF HYPERTENSION AND HYPERLIPIDEMIA, THE PATIENT UNDERWENT LAPAROSCOPIC ONE ANASTOMOSIS GASTRIC BYPASS CONVERSION SURGERY AFTER VERTICAL BANDED GASTROPLASTY. THE GASTRIC POUCH WAS CREATED AND GASTROJEJUNOSTOMY WAS PERFORMED USING A PURPLE RELOAD. THREE WEEKS LATER THE PATIENT HAD A LEFT-UPPER QUADRANT ABDOMINAL PAIN. ABDOMINAL COMPUTERIZED TOMOGRAPHY (CT) SCAN REVEALED A HUGE LEFT SUB DIAPHRAGMATIC COLLECTION ABOUT FOURTEEN CENTIMETERS. THE PATIENT WAS TREATED WITH A PIGTAIL DRAIN INSERTED UNDER ULTRASOUND GUIDANCE. THE DRAIN WAS REMOVED AFTER 2 WEEKS. ONE MONTH LATER, THE FLUID COLLECTION REOCCURRED AND THE PATIENT UNDERWENT REOPERATION WHICH REVEALED A MUCOCELE OF THE GASTRIC REMNANT WHICH WAS RESECTED. IT WAS NOTED THAT MUCOCELE OF THE GASTRIC REMNANT CAN OCCUR WHEN THE STAPLER WAS FIRED TOO CLOSE TO PREVIOUS STAPLER LINE. THE PATIENT HAD AN UNEVENTFUL RECOVERY AND DISCHARGED FORTY EIGHT HOURS POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195067 UNKNOWN ENDO GIA SULU STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN UNKNOWN ENDO GIA SULU

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female Hospitalization| R