BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESOPHYX Z+

    MDR report key: 10975521 · Received December 9, 2020

    Report

    Report Number
    10975521
    Event Type
    Malfunction
    Date Received
    December 9, 2020
    Date of Event
    January 30, 2020
    Report Date
    December 7, 2020
    Manufacturer
    ENDOGASTRIC SOLUTIONS, INC.
    Product Code
    ODE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ENDOGASTRIC SOLUTIONS, INC. ESOPHYX Z+ FASTENER DELIVERY DEVICE WITH SEROSAFUSE FASTENERS MALFUNCTIONED AND WAS UNABLE TO RELOAD AFTER FIRST FIRE ON PATIENT. ONCE USED ON PATIENT, THE MALFUNCTIONED DEVICE WAS DEEMED UNUSABLE BY SALES REPRESENTATIVE AND SURGEONS. THE DEVICE WAS IMMEDIATELY REMOVED FROM FIELD. NO HARM OCCURRED TO PATIENT DURING EVENT AND MANAGEMENT WAS IMMEDIATELY NOTIFIED. THE DEVICE WAS PLACED IN ORIGINAL PACKAGING, AND IS TO BE REVIEWED BY RISK MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1445598 ESOPHYX Z+ ENDOSCOPIC SUTURE/PLICATION SYSTEM, GASTROESOPHAGEAL REFLUX DISEASE (GERD) ODE ENDOGASTRIC SOLUTIONS, INC. R2007 402864

    Patients

    Seq Age Sex Outcome Treatment
    1 21900 DA