BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6T-RS ULTRASOUND PROBE

    MDR report key: 1506302 · Received October 7, 2009

    Report

    Report Number
    9610482-2009-00001
    Event Type
    Malfunction
    Date Received
    October 7, 2009
    Date of Event
    September 22, 2009
    Report Date
    October 7, 2009
    Manufacturer
    GE VINGMED ULTRASOUND AS
    Product Code
    IYN
    PMA / PMN Number
    K033139
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO GE THAT A SIGNIFICANT SECTION OF THE TRANSESOPHAGEAL PROBE ENCLOSURE TIP BECAME SEPARATED FROM THE MAIN PART OF THE PROBE. THE LOSS OF ENCLOSURE EXPOSES THE ESOPHAGUS TO AN ELECTRICAL HAZARD AND SHARP SURFACES THAT CAN MECHANICALLY INJURE THE LUMIN OF THE ESOPHAGUS. FROM THE APPEARANCE OF THE TRANSDUCER, THE EXPOSED AREA IS APPROX 1 TO 2 CM IN LENGTH AND APPEARS TO HAVE RESULTED FROM AN IMPACT INDUCED STRESS OR CRACK THAT WAS NOT DETECTED PRIOR TO INSERTION OF THE PROBE. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURENCE IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6T-RS ULTRASOUND PROBE TRANSESOPHAGEAL ULTRASOUND IYN GE VINGMED ULTRASOUND AS KN100093

    Patients

    Seq Age Sex Outcome Treatment
    1