BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESOPHYX2 - LINK DESIGN - SHORT

    MDR report key: 2931885 · Received January 28, 2013

    Report

    Report Number
    3005473391-2013-00074
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 9, 2013
    Manufacturer
    ENDOGASTRIC SOLUTIONS, INC
    Product Code
    ODE
    PMA / PMN Number
    K092400
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THERE WAS NO INDICATION OF AN INJURY TO THE PATIENT OR A MANUFACTURING PROCESS ISSUE, THIS FAILURE MODE IS NOW BEING REPORTED DUE TO PREVIOUSLY ESTABLISHING THAT IF THIS MALFUNCTION WERE TO REOCCUR, A SERIOUS INJURY MAY OCCUR.

    Description of Event or Problem · 1

    AS THE SURGEON INTRODUCED THE DEVICE INTO THE PATIENT'S UPPER OROPHARYNX, THE ENDOSCOPE RETAINER BAND BROKE. A SECOND DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37820 ESOPHYX2 - LINK DESIGN - SHORT ODE ODE ENDOGASTRIC SOLUTIONS, INC R2002 401366

    Patients

    Seq Age Sex Outcome Treatment
    1