BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLYMPUS

    MDR report key: 646584 · Received November 11, 2005

    Report

    Report Number
    8010047-2005-00122
    Event Type
    Injury
    Date Received
    November 11, 2005
    Date of Event
    September 15, 2005
    Report Date
    October 12, 2005
    Manufacturer
    OLYMPUS OPTICAL CO. LTD.
    Product Code
    GCK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THE PHYSICIAN COULD NOT VISUALIZE THE NEEDLE WHEN HE TRIED TO ADVANCE IT INTO A LESION DURING PROCEDURE. THE PHYSICIAN COMPLETED THE PROCEDURE WITH THE USE OF ANOTHER SIMILAR DEVICE. THE HOSPITAL REPORTED THE PATIENT SUBSEQUENTLY DEVELOPED A PANCREATIC INFECTION AS A RESULT; HOWEVER, THE MEDICAL INTERVENTION USED TO TREAT PATIENT WAS NOT DISCLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS ULTRASONIC GASTROVIDEOSCOPE GCK OLYMPUS OPTICAL CO. LTD. GF-UCT140-A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention