BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA ULTRASOUND GASTROVIDEOSCOPE

    MDR report key: 19949723 · Received August 9, 2024

    Report

    Report Number
    3002808148-2024-07494
    Event Type
    Malfunction
    Date Received
    August 9, 2024
    Report Date
    September 11, 2024
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    ODG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: E1, H3, H6, AND H11. THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION AND DEVICE EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 5 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION A DEFINITIVE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE ESTABLISHED. THE EVENT CAN BE DETECTED/PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE (IFU) WHICH STATE: LABELING REVIEW: AS A RESULT OF CONFIRMING THE INSTRUCTION MANUAL, WE FOUND A DESCRIPTION ABOUT PHENOMENA. REVIEW OF DEVICE HISTORY DOCUMENTS: A RESULT OF CONFIRMING DHR, WE CONFIRMED THAT THE DEVICE CONFORMED TO THE SPEC AND WAS SHIPPED. PRESUMED CAUSE: THE PRODUCT HAS NOT BEEN RETURNED TO QAD OF SHIRAKAWA PLANT AND WE CONDUCTED THE INVESTIGATION FROM THE OBTAINED INFORMATION, BUT WE COULD NOT PRESUME THE CAUSE OF OCCURRENCE OF THE PHENOMENON. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE DEVICE EVALUATION IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE GASTROVIDEOSCOPE EXHIBITED ADHESION OF SCREWS TO FIX THE TIP COVER PEELED OFF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2205130 EVIS LUCERA ULTRASOUND GASTROVIDEOSCOPE ULTRASOUND GASTROVIDEOSCOPE ODG SHIRAKAWA OLYMPUS CO., LTD. GF-UCT260

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown