BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE

    MDR report key: 19952090 · Received August 9, 2024

    Report

    Report Number
    3002808148-2024-07513
    Event Type
    Malfunction
    Date Received
    August 9, 2024
    Date of Event
    July 26, 2024
    Report Date
    September 6, 2024
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    ODG
    UDI-DI
    04953170356339
    PMA / PMN Number
    K093395
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF 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 THREE (3) YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION, AND THE CUSTOMER'S COMPLAINT/REPORTABLE MALFUNCTION WAS CONFIRMED. BASED ON THE INVESTIGATION RESULTS, INSIDE WAS PUNCTURED BY THE NEEDLE (WHEN INSERTING THE PUNCTURE NEEDLE, THE NEEDLE GOT CAUGHT INSIDE THE CHANNEL, AND THE NEEDLE JUMPED OUT), COULD NOT BE IDENTIFIED. THE PRODUCT HAS NOT BEEN RETURNED TO QAD OF SHIRAKAWA PLANT AND THE INVESTIGATION WAS CONDUCTED FROM THE OBTAINED INFORMATION, BUT WE COULD NOT PRESUME THE CAUSE OF THE OCCURRENCE OF THE PHENOMENA. THE EVENTS CAN BE DETECTED AND PREVENTED IN ACCORDANCE WITH THE FOLLOWING SECTIONS OF THE INSTRUCTIONS FOR INSTRUCTIONS FOR USE: ¿AS A RESULT OF CONFIRMING THE INSTRUCTION MANUAL, WE FOUND A DESCRIPTION ABOUT PHENOMENA.¿ OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THE GASTROVIDEOSCOPE PUNCTURE NEEDLE GOT CAUGHT AND PUNCTURED THE CHANNEL. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2486398 EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE ULTRASOUND GASTROVIDEOSCOPE ODG SHIRAKAWA OLYMPUS CO., LTD. GF-UCT180 04953170356339

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown