BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESOPHYX Z+

    MDR report key: 20091463 · Received August 28, 2024

    Report

    Report Number
    3005473391-2024-00232
    Event Type
    Malfunction
    Date Received
    August 28, 2024
    Date of Event
    August 2, 2024
    Report Date
    August 28, 2024
    Manufacturer
    ENDOGASTRIC SOLUTIONS, INC
    Product Code
    ODE
    UDI-DI
    00810275011089
    PMA / PMN Number
    K240879
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE RETURNED DEVICE WAS EVALUATED AT MERIT MEDICAL AND AN ADHESIVE BOND BETWEEN ONE OF THE FASTENER TUBES AND DISTAL SHAFT END WAS FOUND SEPARATED. BASED ON THE AVAILABLE INFORMATION RECEIVED BY EGS, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THERE WAS NO REPORTED PATIENT IMPACT ASSOCIATED WITH THIS INCIDENT AND MERIT MEDICAL DEEMED THE INCIDENT AS NON-REPORTABLE AT THE TIME OF THE INITIAL COMPLAINT. EGS HAS NOW DETERMINED IF THERE IS A RECURRENCE OF THIS MALFUNCTION, A SERIOUS ADVERSE EVENT MAY OCCUR. THEREFORE, THIS INCIDENT IS NOW REPORTABLE.

    Additional Manufacturer Narrative · 0

    THIS MEDWATCH SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR MORE ROBUST DEVICE CODING AND USE OF ANNEX A AS REQUESTED BY THE FDA. MERIT MEDICAL SYSTEMS INC. 1600 WEST MERIT PARKWAY SOUTH JORDAN, UT 84095 (B)(4). CORRECTIONS TO THIS MEDWATCH REPORT: UPDATED A CODES TO INCLUDE 1536, 1384, AND 1670.

    Description of Event or Problem · 0

    A PATIENT UNDERWENT A TRANSORAL INCISIONLESS FUNDOPLICATION (TIF) PROCEDURE. THROUGHOUT THE TIF PROCEDURE, THE PHYSICIAN REPORTED ISSUES WHEN DELIVERING FASTENERS FROM THE ESOPHYX DEVICE AND TROUBLESHOOTED THE PROBLEM. ONE STYLET WAS REPORTEDLY OUTSIDE OF THE GRAY MOLDING AND WOULD NOT RETRACT. THE ESOPHYX DEVICE WAS UNEVENTFULLY REMOVED FORM THE PATIENT. THERE IS NO REPORTED PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1465423 ESOPHYX Z+ ODE ODE ENDOGASTRIC SOLUTIONS, INC R2007 403785 00810275011089

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown