BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESOPHYX 2-LINK

    MDR report key: 3010185 · Received February 14, 2013

    Report

    Report Number
    3010185
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    February 11, 2013
    Report Date
    February 14, 2013
    Manufacturer
    ENDOGASTRIC SOLUTIONS, INC.
    Product Code
    ODE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    SURGEON PERFORMING TIF PROCEDURE. FASTENER CARTRIDGE 7.5 IN PLACE. THE ANTERIOR SIDE OF CARTRIDGE DID NOT DEPLOY FASTENER. THE FASTENER CARTRIDGE 7.5 WAS REPLACED AND SURGERY COMMENCED. STAPLER AND CARTRIDGE WERE SEQUESTERED ALONG WITH PACKAGING.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?SEE ABOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66371 ESOPHYX 2-LINK ENDOSCOPIC PLICATION SYSTEM ODE ENDOGASTRIC SOLUTIONS, INC. * 40145
    66539 ESOPHYX 2-LINK ENDOSCOPIC PLICATION SYSTEM, CARTRIDGE ODE ENDOGASTRIC SOLUTIONS, INC. * 1401245

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR