BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESOPHYX2 - LINK DESIGN - SHORT

    MDR report key: 2514950 · Received April 3, 2012

    Report

    Report Number
    3005473391-2012-00058
    Event Type
    Injury
    Date Received
    April 3, 2012
    Date of Event
    February 24, 2012
    Report Date
    March 5, 2012
    Manufacturer
    ENDOGASTRIC SOLUTIONS, INC
    Product Code
    ODE
    PMA / PMN Number
    K092400
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER?NO ALLEGATION OF PRODUCT MALFUNCTION AND THE DEVICE WAS DISPOSED OF PER THE HOSPITAL'S STANDARD OPERATING PROCEDURE AND IS NOT AVAILABLE FOR AN EVALUATION.

    Description of Event or Problem · 1

    AFTER A TRANSORAL INCISIONLESS FUNDOPLICATION (TIF) PROCEDURE, THE PATIENT WAS IN RECOVERY. LATER THAT EVENING, THE PATIENT BEGAN TO FEEL NAUSEOUS. HE WAS BROUGHT BACK TO THE OPERATING ROOM FOR POST OP BLEEDING AND WAS GIVEN A BLOOD TRANSFUSION. EXPLORATORY LAPAROSCOPY AND ENDOSCOPY INDICATED NO CONTINUED BLOOD LOSS, HOWEVER APPROXIMATELY A LITER OF BLOOD WAS REMOVED FROM THE STOMACH. THE PATIENT WAS KEPT FOR OBSERVATIONS FOR 6 DAYS THEN DISCHARGED. THE PATIENT IS DOING WELL AND IS SYMPTOM FREE WITH NO REFLUX SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESOPHYX2 - LINK DESIGN - SHORT ODE ODE ENDOGASTRIC SOLUTIONS, INC R2002 401225

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Hospitalization| R