BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESOPHYX Z+

    MDR report key: 20110371 · Received August 30, 2024

    Report

    Report Number
    3005473391-2023-00501
    Event Type
    Malfunction
    Date Received
    August 30, 2024
    Date of Event
    February 6, 2024
    Report Date
    August 29, 2024
    Manufacturer
    ENDOGASTRIC SOLUTIONS INC
    Product Code
    ODE
    PMA / PMN Number
    K172811
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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 RETURNED FOR ENGINEERING EVALUATION. THE COMPLAINT IS 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.

    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 801-253-1600 CORRECTIONS TO MEDWATCH REPORT IS AS FOLLOWS: UPDATED F CODES TO INCLUDE: 4604 UPDATED A CODES TO INCLUDE 3009,1384, 2920 AND 1670 UPDATED THE MANUFACTURE NARRATIVE TO REFLECT CORRECT VERBIAGE. ""THE SUSPECT MEDICAL DEVICE WAS RETURNED FOR ENGINEERING EVALUATION. THE COMPLAINT IS 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.".

    Description of Event or Problem · 0

    THE ACCOUNT ALLEGES THAT A PATIENT UNDERWENT A TRANSORAL INCISIONLESS FUNDOPLICATION (TIF) AND HIATAL HERNIA [HH] REPAIR. POST DILATION WITH 60F BOUGIE WITH NOTED RESISTANCE WAS NOTED. THE PHYSICIAN ATTEMPTED TO INSERT THE DEVICE INTO THE PATIENT AND WAS HAVING DIFFICULTY ADVANCING THE DEVICE AND ENDOSCOPE PAST THE TRACHEAL LARYNX OF THE PATIENT. THE ANESTHESIOLOGIST ALSO NOTED DIFFICULTY OPENING THE PATIENT'S JAW AND ADVANCING ENDOTRACHEAL TUBING. THE PHYSICIAN DECIDED TO REMOVE THE DEVICE FROM THE PATIENT TO ADD LUBRICANT. ON-DEVICE REMOVAL, THE HELIX WAS NOTED AS STICKING OUT OF THE DEVICE. THE PHYSICIAN WAS ABLE TO SAFELY STOW ALL SHARPS WHEN REMOVING THE DEVICE. THE HELIX LOCK WAS CONFIRMED IN THE LOCKED POSITION BY THE PHYSICIAN. BLOOD WAS NOTED ON THE DISTAL END OF THE DEVICE AFTER REMOVAL. SOME GI TEARS WERE NOTED AS WELL. NO MEDICAL INTERVENTION OR BLOOD TRANSFUSION WAS REQUIRED. THE PROCEDURE WAS ABORTED. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1097301 ESOPHYX Z+ ENDOSCOPIC SUTURE/PLICATION SYSTEM ODE ENDOGASTRIC SOLUTIONS INC 403315

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown