BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA ULTRASOUND GASTROVIDEOSCOPE

    MDR report key: 15988630 · Received December 15, 2022

    Report

    Report Number
    3002808148-2022-05267
    Event Type
    Malfunction
    Date Received
    December 15, 2022
    Date of Event
    November 17, 2022
    Report Date
    January 17, 2023
    Manufacturer
    SHIRAKAWA OLYMPUS CORP. LTD.
    Product Code
    ODG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AT THIS TIME, IT HAS BEEN INDICATED TO OLYMPUS THAT THE DEVICE WILL NOT BE RETURNED FOR TESTING AND EVALUATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, OR THE EVALUATION IS COMPLETED, A FOLLOW UP REPORT WILL BE SUBMITTED. DETAILED BREAKDOWN OF CONCOMITANT MEDICAL PRODUCTS: EU-ME2(7915402)ENDOSCOPIC ULTRASOUND CENTER, MAJ-2056 ULTRASOUND CABLE, CV-290 VIDEO SYSTEM CENTER, CLV-290 LIGHT SOURCE.

    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. BASED ON THE RESULTS OF THE INVESTIGATION, THE DEVICE WAS NOT RETURNED FOR EVALUATION, THE DEFINITIVE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS THE EVIS LUCERA ULTRASOUND GASTROVIDEOSCOPE IMAGE DISAPPEARED, AND A MESSAGE WAS RECEIVED STATING ¿ACTIVATION EXPIRED.¿ THE REPORTED ISSUE OCCURRED DURING AN UNKNOWN DIAGNOSTIC PROCEDURE. THE DEVICE WAS REMOVED, THEN POWERED OFF AND ON AS A RESULT THE IMAGE WAS RESTORED. THE PROCEDURE WAS SUBSEQUENTLY COMPLETED WITH THE SAME DEVICE WITH NO REOCCURRENCE OF THE ISSUE. THE DEVICE WAS INSPECTED WITH NO ABNORMALITIES FOUND PRIOR TO USE. THERE WAS NO PATIENT/USER HARM OR INJURY REPORTED DUE TO THE EVENT.

    Description of Event or Problem · 0

    IT WAS LATER PROVIDED THE PROCEDURE PERFORMED WAS A DIAGNOSIS OF THE DEGREE OF INVASION OF ENDOSCOPIC ULTRASOUND (EUS) LESIONS. THE PROCEDURE WAS DELAYED APPROXIMATELY FIVE (5) MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2571218 EVIS LUCERA ULTRASOUND GASTROVIDEOSCOPE ULTRASOUND GASTROVIDEOSCOPE ODG SHIRAKAWA OLYMPUS CORP. LTD. GF-UCT260

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ULTRASOUND CTR, CABLE, VIDEO SYS CTR, LIGHT SOURCE