BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSESOPHAGEAL ENDOSCOPIC (TEE) PROBE

    MDR report key: 324774 · Received June 15, 2001

    Report

    Report Number
    1218950-2001-00119
    Event Type
    Injury
    Date Received
    June 15, 2001
    Date of Event
    December 11, 2000
    Report Date
    March 9, 2001
    Manufacturer
    AGILENT TECHNOLOGIES, INC.
    Product Code
    ITX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PT HAD A TRANSESOPHAGEAL ECHOCARDIOGRAM USING THE "TEE" PROBE THAT HAD BEEN DISINFECTED WITH CIDEX "OPA." DISCOLORATION OF ORAL MUCOSA ESOPHAGUS WAS NOTED THE FOLLOWING DAY. THE RESULTS OF DIRECT LARYNGOSCOPY WERE NORMAL, BUT ONE WEEK LATER, THERE WAS EROSIVE ESOPHAGITIS ON ENDOSCOPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27479 TRANSESOPHAGEAL ENDOSCOPIC (TEE) PROBE DIAGNOSTIC ULTRASOUND TRANSDUCER ITX AGILENT TECHNOLOGIES, INC. 21369A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Other