BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESOPHYX2

    MDR report key: 2423568 · Received January 13, 2012

    Report

    Report Number
    2423568
    Event Type
    Malfunction
    Date Received
    January 13, 2012
    Date of Event
    January 11, 2012
    Report Date
    January 13, 2012
    Manufacturer
    ENDOGASTRIC SOLUTIONS, INC.
    Product Code
    ODE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE USING AN ENDOSCOPIC FUNDOPLICATION DEVICE THE PHYSICIAN ATTEMPTED TO DEPLOY THE H-FASTENERS TO CREATE THE FUNDOPLICATION, THE DEVICE FAILED. ONLY ONE FASTENER DEPLOYED.======================MANUFACTURER RESPONSE FOR ENDOSCOPIC PLICATION SYSTEM, ESOPHYX2 SYSTEM (PER SITE REPORTER).======================AWAITING THEIR REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESOPHYX2 ENDOSCOPIC PLICATION SYSTEM ODE ENDOGASTRIC SOLUTIONS, INC. R2000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR