BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESOPHYX Z+

    MDR report key: 20081883 · Received August 27, 2024

    Report

    Report Number
    3005473391-2023-00500
    Event Type
    Injury
    Date Received
    August 27, 2024
    Date of Event
    December 2, 2022
    Report Date
    August 27, 2024
    Manufacturer
    ENDOGASTRIC SOLUTIONS INC
    Product Code
    ODE
    UDI-DI
    00810275011089
    PMA / PMN Number
    K172811
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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. A REPORTABLE EVENT 3500A MEDWATCH WAS NOT SUBMITTED TO THE FDA FOR THIS COMPLAINT. THE SUSPECT MEDICAL DEVICE WAS DISCARDED AND 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 A MALE PATIENT UNDERWENT A TRANSORAL INCISIONLESS FUNDOPLICATION [TIF] PROCEDURE FOR GERD. THE PATIENT HAD A SEVERE COUGH, THAT WAS UNRELATED TO THE PROCEDURE WHEN DISCHARGED FROM THE HOSPITAL. THE PATIENT PRESENTED AGAIN 11 DAYS POST-TIF PROCEDURE FOR A GI PERFORATION ON THE ANTERIOR SIDE OF THE FASTENERS. IT IS UNKNOWN WHAT CAUSED OR CONTRIBUTED TO THE FASTENER FAILURES OR THE ALLEGED GI PERFORATION. THE CHEST TUBES WERE ALSO PLACED IN THIS PATIENT TO PREVENT IMPAIRMENT. THE DEVICE WAS NOT RETURNED FOR ENGINEERING OBSERVATION AND THERE ARE NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT. THE PATIENT TOLERATED THE PROCEDURES AND INTERVENTIONS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1494112 ESOPHYX Z+ ENDOSCOPIC SUTURE/PLICATION SYSTEM ODE ENDOGASTRIC SOLUTIONS INC 00810275011089

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention| H| L