BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSESOPHAGEAL ENDOSCOPIC (TEE) PROBE

    MDR report key: 349230 · Received August 28, 2001

    Report

    Report Number
    1218950-2001-00201
    Event Type
    Injury
    Date Received
    August 28, 2001
    Date of Event
    August 14, 2001
    Report Date
    August 14, 2001
    Manufacturer
    AGILENT TECHNOLOGIES, INC.
    Product Code
    ITX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PT'S ESOPHAGUS WAS RUPTURED DURING INSERTION OF THE 21369A TRANSESOPHAGEAL ENDOSCOPIC (TEE) PROBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39049 TRANSESOPHAGEAL ENDOSCOPIC (TEE) PROBE DIAGNOSTIC ULTRASOUND TRANSDUCER ITX AGILENT TECHNOLOGIES, INC. 21369A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention