BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESOPHYX Z+

    MDR report key: 20079844 · Received August 27, 2024

    Report

    Report Number
    3005473391-2023-00207
    Event Type
    Injury
    Date Received
    August 27, 2024
    Date of Event
    December 14, 2023
    Report Date
    August 26, 2024
    Manufacturer
    ENDOGASTRIC SOLUTIONS INC
    Product Code
    ODE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A MEDWATCH SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO A RETROSPECTIVE REVIEW OF EGS COMPLAINTS [(B)(4)] BY MERIT MEDICAL'S SYSTEMS INC, [(B)(4)] PMS TEAM FOR ANY IDENTIFIED COMPLAINT DISCREPANCIES REQUIRING CORRECTIONS/ADDITIONAL INFORMATION PER 21 CFR 803. MERIT MEDICAL SYSTEMS INC. (B)(6). CORRECTIONS TO EGS MEDWATCH REPORT: B.2 - UPDATED TO INCLUDE [X] LIFE-THREATENING [X] HOSPITALIZATION. UPDATED F CODE TO INCLUDE 4617, 4607.

    Additional Manufacturer Narrative · 0

    A MEDWATCH INITIAL FINAL REPORT IS BEING SUBMITTED DUE TO A RETROSPECTIVE REVIEW OF EGS COMPLAINTS [(B)(4)] BY MERIT MEDICAL'S SYSTEMS INC, [(B)(4)] PMS TEAM FOR ANY IDENTIFIED COMPLAINT DISCREPANCIES REQUIRING SUBMISSIONS, CORRECTIONS AND/OR ADDITIONAL INFORMATION PER 21 CFR 803. AN INITIAL REPORT WAS NOT SUBMITTED. THE SUSPECT MEDICAL DEVICE WAS NOT RETURNED FOR DEVICE EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO EXCEPTION DOCUMENTS WERE FOUND. SHOULD THE DEVICE RETURN AT A LATER DATE THE COMPLAINT WILL BE RE-OPENED. MERIT MEDICAL SYSTEMS INC. 1600 WEST MERIT PARKWAY, SOUTH JORDAN, UT 84095, 801-253-1600.

    Description of Event or Problem · 0

    THE ACCOUNT ALLEGES THAT A PATIENT UNDERWENT A HIATAL HERNIA REPAIR TO FOLLOW WITH A TRANSORAL INCISIONLESS FUNDOPLICATION [CTIF] PROCEDURE. ONE BOUGIE [60F] WAS USED TO DILATATE THE PATIENT'S ESOPHAGUS BEFORE THE TIF PROCEDURE. POST-PROCEDURE THE PATIENT WAS ADMITTED OVERNIGHT FOR OBSERVATION DUE TO THE LARGE SIZE OF THE HIATAL HERNIA REPAIR. THE PATIENT REPORTEDLY HAD A DROP IN HEMOGLOBIN (HGB) AND EXPERIENCED MELENA AND FATIGUE. THE NEXT DAY A ESOPHAGOGASTODUODENOSCOPY [EGD] WAS ORDERED. THE PATIENT WAS DIAGNOSED WITH A LARGE RETROESOPHAGEAL MEDIASTINAL HEMATOMA AND HEMORRHAGING. AS OF DEC 21ST, THE PATIENT IS DOING WELL WITH NO ADDITIONAL CONSEQUENCES TO REPORT. THE DEVICE WAS NOT RETURNED FOR ENGINEERING EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1493706 ESOPHYX Z+ ENDOSCOPIC SUTURE/PLICATION SYSTEM ODE ENDOGASTRIC SOLUTIONS INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| L| R