BEUDAMED
    FDA Adverse Event Other Summary report: N

    ESOPHYX 2.7

    MDR report key: 2601855 · Received August 12, 2008

    Report

    Report Number
    3005473391-2008-00005
    Event Type
    Other
    Date Received
    August 12, 2008
    Date of Event
    June 5, 2008
    Report Date
    August 8, 2008
    Manufacturer
    ENDOGASTRIC SOLUTIONS, INC.
    Product Code
    ODE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A PT WAS ADMITTED TO THE HOSPITAL DUE TO... THE PT COMPLAINED OF DIZZINESS AND SYNCOPAL TYPE SYMPTOMS. HE WAS ADMITTED WITH AN HCT OF 20. THE PT WAS POST PROCEDURE BY 10 DAYS. THE STOMACH WAS VISUALIZED THROUGH AN ENDOSCOPE BUT NO ACTIVE BLEEDING WAS SEEN. THE PT WAS TRANSFUSED, KEPT OVERNIGHT FOR OBSERVATION AND WAS RELEASED THE NEXT DAY. ACCORDING TO THE PHYSICIAN, ONE BLEEDER WAS SEEN DURING THE ORIGINAL PROCEDURE WITH APPROX 100CC OF BLOOD LOSS. THE BLEEDER WAS CLAMPED WITH THE TISSUE MOLD FOR FIVE MINS TO ALLOW CLOTTING. NO MORE BLOOD WAS SEEN AND THE PROCEDURE WAS CONTINUED AND ENDED SUCCESSFULLY WITH A VERY GOOD VALVE FORMED. THE PHYSICIAN EMPHASIZED THAT BLEEDING IN A SURGICAL ENVIRONMENT IS EXPECTED AND PIERCING A BLOOD VESSEL IN THE TISSUE IS ALSO EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESOPHYX 2.7 ODE ENDOGASTRIC SOLUTIONS, INC. 2.7 NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization TWO UNITS, BLOOD