BEUDAMED
    FDA Adverse Event Other Summary report: N

    TEE/8-3 MHZ TRANSDUCER

    MDR report key: 2655806 · Received June 1, 2009

    Report

    Report Number
    3032367-2009-00004
    Event Type
    Other
    Date Received
    June 1, 2009
    Date of Event
    April 23, 2009
    Report Date
    June 1, 2009
    Manufacturer
    SONOSITE,INC.
    Product Code
    IYO
    PMA / PMN Number
    K071134
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS USING METRICIDE OPA AS A CLEANING AGENT, WHICH IS NOT ONE OF THE DISINFECTANTS RECOMMENDED FOR USE ONLY THOSE DISINFECTANTS THAT HAVE BEEN RECOMMENDED FOR USE WITH THE TEE TRANSDUCER AND IN DOING SO TO ENSURE THEY FOLLOW THE MFR'S INSTRUCTIONS FOR USE WHEN CLEANSING AND RINSING THEIR TRANSDUCER. IN ADDITION, THEY WERE PROVIDED A COPY OF THE TEE USER GUIDE AND TEE CARE INSTRUCTIONS WHICH LISTS ALTERNATE CLEANING METHODS THAT HAVE BEEN APPROVED FOR USE WITH THE TEE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A SONOSITE TEE/8-3 MHZ TRANSESOPHAGEAL TRANSDUCER LEFT BLACK MARKS ON THE PT'S LIPS AND TONGUE IN THE AREA WHERE THE TRANSDUCER SHAFT RESTED AGAINST THE PT. NO PERMANENT DAMAGE OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEE/8-3 MHZ TRANSDUCER TRANSESOPHAGEAL ULTRASOUND TRANSDUCER IYO SONOSITE,INC. P06841

    Patients

    Seq Age Sex Outcome Treatment
    1