BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESOPHYX Z+ OR SEROSAFUSE IMPLANTABLE FASTENER

    MDR report key: 17505359 · Received August 10, 2023

    Report

    Report Number
    3005473391-2023-00191
    Event Type
    Injury
    Date Received
    August 10, 2023
    Date of Event
    July 5, 2023
    Report Date
    March 1, 2024
    Manufacturer
    ENDOGASTRIC SOLUTIONS, INC
    Product Code
    ODE
    PMA / PMN Number
    K172811
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATING HEALTH EFFECT CLINICAL CODE (E) TO ONLY INCLUDE: 2010, 4580, AND 4581. UPDATING HEALTH EFFECT IMPACT CODE (F) TO ONLY INCLUDE: 4614, 4641, 4607, 4649, AND 4639. UPDATING TYPE OF INVESTIGATION (B) TO ONLY INCLUDE: 4115, 4112, AND 4119. UPDATING INVESTIGATION FINDINGS (C) TO ONLY INCLUDE: 213. UPDATING INVESTIGATION CONCLUSIONS (D) TO ONLY INCLUDE: 4315. HEALTH EFFECT CLINICAL CODE (E) CODE 4581 USED AS "ATELECTASIS" IS NOT AN EXISTING TERM IN ANNEX E.

    Additional Manufacturer Narrative · 0

    CORRECTED B3: DATE OF EVENT AND B4: DATE OF THIS REPORT.

    Additional Manufacturer Narrative · 0

    CURRENTLY IT IS UNKNOWN WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED TO ENDOGASTRIC SOLUTIONS (EGS) FOR EVALUATION. THE INVESTIGATION IS ONGOING, AND A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY ENDOGASTRIC SOLUTIONS, WHICH THE COMPANY HAS NOT BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA.

    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 EVENT. B.7 HISTORY UPDATED TO INCLUDE. GERD, HIATAL HERNIA, STRICTURES, DRAINAGE TUBES, ASPIRATION PNEUMONIA. D6A - IMPLANT DATE - ADDED. UPDATED E CODES TO INCLUDE 1735. UPDATED F CODES TO INCLUDE 4617. UPDATED A CODES TO INCLUDE 2993. UPDATED G CODE TO 788. REPLACED C CODE TO INCLUDE 3221. REPLACED D CODE TO INCLUDE 67. H.8 UPDATED TO REFLECT [X] INITIAL USE.

    Description of Event or Problem · 0

    A PATIENT UNDERWENT A HIATAL HERNIA REPAIR (HHR) PROCEDURE FOLLOWED BY A TRANSORAL INCISIONLESS FUNDOPLICATION (TIF) PROCEDURE AND A NONDESCRIPT PRODUCT MALFUNCTION AND ADVERSE EVENTS WERE REPORTED. THE REPORTED ADVERSE EVENTS ARE SYMPATHETIC PLEURAL EFFUSION AND ATELECTASIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1072618 ESOPHYX Z+ OR SEROSAFUSE IMPLANTABLE FASTENER ODE ODE ENDOGASTRIC SOLUTIONS, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| R| H BOUGIE USE| ENDOSCOPE O,YMPUS 190