BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIVID I WITH 6TC-RS PROBE

    MDR report key: 2080478 · Received April 22, 2011

    Report

    Report Number
    9610482-2011-00003
    Event Type
    Injury
    Date Received
    April 22, 2011
    Date of Event
    March 25, 2011
    Report Date
    April 21, 2011
    Manufacturer
    GE VINGMED ULTRASOUND AS
    Product Code
    IYN
    PMA / PMN Number
    K082374
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE (B)(4) PERSONAL INFORMATION PROTECTION LAW PREVENTS THE DISCLOSURE OF PATIENT INFORMATION. INITIAL REPORTER'S NAME AND OCCUPATION WAS NOT PROVIDED. THE SITE WAS CONTACTED BY A GE HEALTHCARE REPRESENTATIVE. IN DISCUSSION CONCERNING THE INCIDENT, A SITE REPRESENTATIVE STATED THE ESOPHAGEAL PERFORATION WAS CAUSED BY AN OPERATOR ERROR DURING THE PROCEDURE. THE OPERATOR DID NOT MOVE THE PROBE GENTLY AND THE TIP OF THE PROBE WAS NOT PARALLEL WITH THE DIRECTION OF INTENDED INSERTION. THERE WAS NO DEVICE MALFUNCTION. THE OPERATOR HAS ACCEPTED FULL RESPONSIBILITY FOR THE ERROR DURING THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED AN ESOPHAGEAL PERFORATION DURING A TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) PROCEDURE. THE PATIENT OUTCOME HAS NOT BEEN DISCLOSED BY THE SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIVID I WITH 6TC-RS PROBE ULTRASONIC IMAGING SYSTEM IYN GE VINGMED ULTRASOUND AS KN200103

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention