BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMAGEPOINT

    MDR report key: 297366 · Received September 22, 2000

    Report

    Report Number
    1218950-2000-00083
    Event Type
    Injury
    Date Received
    September 22, 2000
    Date of Event
    August 21, 2000
    Report Date
    August 22, 2000
    Manufacturer
    AGILENT TECHNOLOGIES, INC.
    Product Code
    IYN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE INSERTING THE ACCESSORY "TEE" PROBE THE PHYSICIAN HAD EXTREME DIFFICULTY AND HAD TO BEGIN OVER SEVERAL TIMES. ON ABOUT THE SEVENTH TIME HE WAS FINALLY ABLE TO PASS THE PROBE ENOUGH TO ACQUIRE CARDIAC IMAGES. DURING THE EXAM THE PHYSICIAN NOTICED THAT THE IMAGE WAS OBSCURED DUE TO THE PRESENCE OF AIR. AFTER THE EXAM BLOOD WAS DETECTED ON THE PROBE. PT SUFFERED A PERFORATED ESOPHAGUS FROM THE PROCEDURE. FOLLOWING THIS INJURY THE PT HAD SURGERY TO REPAIR A PHARYNGEAL ESOPHAGEAL LACERATION. ALSO CHEST TUBES WERE INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMAGEPOINT IMAGEPOINT IYN AGILENT TECHNOLOGIES, INC. M2410A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention