BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GE HEALTHCARE 6TC TEE PROBE

    MDR report key: 2867660 · Received December 7, 2012

    Report

    Report Number
    9610482-2012-00009
    Event Type
    Injury
    Date Received
    December 7, 2012
    Date of Event
    November 7, 2012
    Report Date
    November 8, 2012
    Manufacturer
    GE VINGMED ULTRASOUND AS
    Product Code
    IYN
    PMA / PMN Number
    K081921
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UNDER EUROPEAN LAW AND (B)(6), PT INFO IS CONSIDERED CONFIDENTIAL AND WILL NOT BE RELEASED BY THE HOSPITAL. DEVICE MANUFACTURE DATE IS UNAVAILABLE AT THIS TIME. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT MAY HAVE SUFFERED AN ESOPHAGEAL TEAR DURING A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). THE PT WAS UNDER ANESTHESIA DURING THE PROCEDURE. THE HEALTHCARE PROFESSIONAL PERFORMED THE TEE DESCRIBED DIFFICULTY PLACING THE GE TEE PROBE AND OBSERVED A MODERATE AMOUNT OF BLOOD DURING THE SCAN, HOWEVER, THE SCAN WAS COMPLETED AND THE PT APPEARED NORMAL. "HOURS LATER", SWELLING TO THE PT WAS OBSERVED AND THE PT WAS SCHEDULED TO HAVE A CT SCAN. NO FURTHER SEQUELAE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GE HEALTHCARE 6TC TEE PROBE TRANS-ESOPHAGEAL ECHOCARDIOGRAPHY PROBE IYN GE VINGMED ULTRASOUND AS K100092

    Patients

    Seq Age Sex Outcome Treatment
    1 Other