BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TE ULTRASOUND TRANSDUCER

    MDR report key: 1950220 · Received December 9, 2010

    Report

    Report Number
    9610482-2010-00005
    Event Type
    Malfunction
    Date Received
    December 9, 2010
    Date of Event
    November 9, 2010
    Report Date
    December 9, 2010
    Manufacturer
    GE VINGMED ULTRASOUND AS
    Product Code
    IYN
    PMA / PMN Number
    K081921
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A SITE REPORTED HAVING DIFFICULTIES REMOVING THE TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) PROBE FROM THE PT'S ESOPHAGUS. THE PT WAS REPORTEDLY TAKEN TO THE GI/IR LAB WHERE REMOVAL WAS ASSISTED UNDER FLUOROSCOPIC IMAGING. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE 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 TE ULTRASOUND TRANSDUCER TRANSESOPHAGEAL ULTRASOUND IYN GE VINGMED ULTRASOUND AS

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR