BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESOPHYX Z+

    MDR report key: 20110643 · Received August 30, 2024

    Report

    Report Number
    3005473391-2023-00502
    Event Type
    Malfunction
    Date Received
    August 30, 2024
    Date of Event
    October 9, 2023
    Report Date
    August 30, 2024
    Manufacturer
    ENDOGASTRIC SOLUTIONS INC
    Product Code
    ODE
    PMA / PMN Number
    K172811
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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 OR FAILED TO PASS SUBMISSION FOR THIS EVENT. THE SUSPECT MEDICAL DEVICE WAS NOT RETURNED FOR ENGINEERING 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. A SEARCH OF THE COMPLAINT DATABASE WAS PERFORMED AND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER WERE IDENTIFIED. SHOULD THE DEVICE BE RETURNED LATER, THE INVESTIGATION WILL BE REOPENED. REVIEWED FOR EGS - 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 POST-TRANSORAL INCISIONLESS FUNDOPLICATION (TIF) AND HIATAL HERNIAS [HH] REPAIR PROCEDURES, THE PATIENT PRESENTED TO THE HOSPITAL WITH STOMACH PAIN, IMAGING REVEALED HEMORRHAGING BEHIND HIS STOMACH. THE PATIENT WAS NOT ADMITTED AND WAS LATER SENT HOME THAT DAY. THE PHYSICIAN STATES THAT IT IS UNKNOWN IF THE COLLECTION OF FLUID/HEMORRHAGING WAS BECAUSE OF THE TIF, OR THE HIATAL HERNIA REPAIR PROCEDURES. NO MEDICAL INTERVENTION OR BLOOD TRANSFUSION WAS REQUIRED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1597218 ESOPHYX Z+ ENDOSCOPIC SUTURE/PLICATION SYSTEM ODE ENDOGASTRIC SOLUTIONS INC 403483

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening