BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS ULTRASONIC GASTROVIDEOSCOPE

    MDR report key: 1850465 · Received September 21, 2010

    Report

    Report Number
    8010047-2010-00177
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Date of Event
    August 23, 2010
    Report Date
    August 24, 2010
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    ODG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ULTRASOUND GASTROSCOPE WAS RETURNED TO OLYMPUS FOR EVALUATION. THE EVALUATION CONFIRMED THE USER'S REPORT OF ULTRASOUND IMAGE DIFFICULTY, HOWEVER, THE VIDEO IMAGE WAS FOUND TO OPERATE APPROPRIATELY. THE ULTRASOUND IMAGE WAS FOUND TO CONTAIN HEAVY STATIC. MULTIPLE DENTS AND SCRATCHES WERE NOTED ON THE PROBE UNIT THAT LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE DEVICE HAS BEEN SERVICED AND RETURNED TO THE USER FACILITY. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING AN ENDOSCOPIC ULTRASOUND NEEDLE ASPIRATION THE USER EXPERIENCED ULTRASOUND IMAGE DIFFICULTY. THERE WAS NO TOTAL LOSS OF IMAGE EXPERIENCED, HOWEVER, THE LIGHTNESS OF THE ULTRASOUND IMAGE REPORTEDLY MADE IT DIFFICULT FOR THE DR. TO VISUALIZE THE CYST AND COMPLETE THE PROCEDURE. THE PROCEDURE WAS ABORTED. THERE WAS NO PATIENT INJURY REPORTED, HOWEVER, USER FACILITY PERSONNEL STATED THAT A FOLLOW-UP PROCEDURE HAS NOT YET BEEN SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS ULTRASONIC GASTROVIDEOSCOPE GASTROSCOPE ODG OLYMPUS MEDICAL SYSTEMS CORPORATION GF-UCT140-AL5 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization