BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE HEALTHCARE 6TC TEE PROBE

    MDR report key: 2688130 · Received August 7, 2012

    Report

    Report Number
    9610482-2012-00007
    Event Type
    Malfunction
    Date Received
    August 7, 2012
    Date of Event
    June 7, 2012
    Report Date
    June 26, 2012
    Manufacturer
    GE VINGMED ULTRASOUND AS
    Product Code
    DXK
    PMA / PMN Number
    K081921
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED ON (B)(6) 2012, THAT A PATIENT SUFFERED SOFT TISSUE INJURY BEHIND THE PALETTE WITH SOME BLEEDING AFTER THE CARDIOLOGIST EXPERIENCED DIFFICULTY INSERTING THE GE TRANS-ESOPHAGEAL ECHOCARDIOGRAPHY (TEE) PROBE. AFTER SEVERAL ATTEMPTS TO OBTAIN ADDITIONAL DETAILS OF THE INJURY, THE INITIAL REPORTER RESPONDED ON (B)(6) 2012, REPORTING SWELLING AND SPASM OF THE EPIGLOTTIS, EXCESSIVE PROBE STIFFNESS THAT REQUIRED REPEATED INSERTION ATTEMPTS, SIGNIFICANT PRESSURE, AND SUBSTANTIAL USE OF VISCOUS LIDOCAINE AND VERSED. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GE HEALTHCARE 6TC TEE PROBE TRANS-ESOPHAGEAL ECHOCARDIOGRAPHY PROBE DXK GE VINGMED ULTRASOUND AS KN100105

    Patients

    Seq Age Sex Outcome Treatment
    1 Other