BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASONIC GASTROVIDEOSCOPE

    MDR report key: 15346813 · Received September 2, 2022

    Report

    Report Number
    3002808148-2022-01652
    Event Type
    Malfunction
    Date Received
    September 2, 2022
    Date of Event
    August 4, 2022
    Report Date
    November 1, 2022
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    ODG
    UDI-DI
    04953170356261
    PMA / PMN Number
    K051541
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION AND THE CUSTOMER'S ALLEGATION WAS CONFIRMED. THE DEVICE EVALUATION DETERMINED THAT THE LIGHT GUIDE BUNDLE HAD BREAKAGE WHICH DIMMED THE LUMENS. THE EVALUATION ALSO FOUND MINOR SCRATCHES ON THE CHANNEL BODY, CAP, BENDING AREA, LIGHT GUIDE PRONG/MOUNT, LABELS, AND ULTRASOUND MEDICAL CORD. THERE WAS PEELING AND CRACKED GLUE AROUND THE BENDING AREA AND THE LIGHT GUIDE LENS. THE INSERTION TUBE HAD MINOR PEELING. THE SCOPE CONNECTOR AND ELECTRICAL CONNECTOR HAD CORROSION. THE CONTROL KNOB HAD SOME PLAY. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 7 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, THE SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED AT THIS TIME. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS, THE ULTRASONIC GASTROVIDEOSCOPE HAD NO LIGHT COMING FROM THE LIGHT GUIDE LENS. THE EVENT WAS FOUND DURING PREPARATION FOR USE. INSPECTION AND TESTING OF THE RETURNED DEVICE FOUND THAT THE LIGHT ON THE SCOPE WAS BROKEN. THERE WERE NO REPORTS OF PATIENT HARM. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1339997 ULTRASONIC GASTROVIDEOSCOPE ULTRASONIC GASTROVIDEOSCOPE ODG SHIRAKAWA OLYMPUS CO., LTD. GF-UE160-AL5 04953170356261

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown