BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRANSESOPHAGEAL ENDOSCOPIC (TEE) PROBE

    MDR report key: 863272 · Received June 8, 2007

    Report

    Report Number
    2518586-2007-00001
    Event Type
    Other
    Date Received
    June 8, 2007
    Report Date
    May 14, 2007
    Manufacturer
    PHILIPS ULTRASOUND, INC.
    Product Code
    ITX
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER REQUESTED VERIFICATION THEIR SYSTEM HAS AN EFFECTIVE TRANSDUCER TEMPERATURE WARNING SIGNAL. AN ANALYSIS OF THE SYSTEM AND TRANSDUCER BY PHILIPS PERSONNEL, CONFIRMED THEIR PROPER FUNCTION AND NO PROBLEMS WERE IDENTIFIED. THE CUSTOMER WAS ALSO ADVISED THAT IF THE WARNING SIGNAL IS IGNORED, THE SYSTEM WOULD AUTOMATICALLY BECOME DISABLED AND NO FURTHER IMAGING CAN BE PERFORMED. THE CUSTOMER WAS SATISFIED WITH THE FINDINGS AND FELT CONFIDENT THAT THEIR DEVICE WAS FUNCTIONING PROPERLY. THEY CONTINUE TO USE THE SYSTEM AND TRANSDUCER.

    Description of Event or Problem · 1

    PATIENT DEVELOPED A BURN SCAR TO ESOPHAGEAL AREA FOLLOWING TEE EXAMINATION. PATIENT HAD PRE-EXISTING SCARS IN THE GASTRO-ESOPHAGEAL AND WAS UNDER STEROID TREATMENT WHICH HEIGHTENED THE PATIENT'S SENSITIVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSESOPHAGEAL ENDOSCOPIC (TEE) PROBE TEE PROBE ITX PHILIPS ULTRASOUND, INC. 21378-68000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other STEROID