BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESOPHYX2 HD SYSTEM

    MDR report key: 5063646 · Received September 9, 2015

    Report

    Report Number
    5063646
    Event Type
    Malfunction
    Date Received
    September 9, 2015
    Date of Event
    August 28, 2015
    Report Date
    September 2, 2015
    Manufacturer
    ENDOGASTRIC SOLUTIONS INC.
    Product Code
    ODE
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DOCTOR PERFORMING TRANSORAL INCISION-LESS FUNDOPLICATION. ESOPHYX2 HD DEVICE WAS IN USE, SPRINGS BROKE ON THE DEVICE MAKING THE FASTENERS UNUSABLE. A SECOND ESOPHYX2 HD WAS OPENED AND DOCTOR WAS ABLE TO COMPLETE THE PROCEDURE. COMPANY REP WAS IN ROOM AT THE TIME OF MALFUNCTION. MANUFACTURER RESPONSE FOR FASTENER DELIVERY SYSTEM, ESOPHYX 2 HD (PER SITE REPORTER): UNKNOWN, REP AWARE AT TIME OF SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597664 ESOPHYX2 HD SYSTEM ENDOSCOPIC SUTURE/PLICATION SYSTEM, GASTROESOPHAGEAL REFLUX DISEASE (GERD) ODE ENDOGASTRIC SOLUTIONS INC. 401977

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR UNKNOWN AT THIS TIME