BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 22214603 · Received June 16, 2025

    Report

    Report Number
    9610595-2025-11342
    Event Type
    Malfunction
    Date Received
    June 16, 2025
    Date of Event
    April 15, 2025
    Report Date
    December 5, 2025
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H10 - RELATED REPORT NUMBERS: MW5170038, MW5170040, MW5170041, MW5170042, MW5170043, MW5170044, MW5170045, MW5170046. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. SINCE THE DEVICE MODEL WAS UNKNOWN OLYMPUS SELECTED ¿AIZU OLYMPUS CO., LTD.¿ AS A REPRESENTATIVE REPORTING SITE. UPDATED FIELDS: H6. THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THE MOST PROBABLE CAUSE WAS NOT ESTABLISHED; THE INVESTIGATION FINDINGS DO NOT LEAD TO A CLEAR CONCLUSION ABOUT THE CAUSE OF THE REPORTED ADVERSE EVENT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A COLONOSCOPY SAMPLE HAD BEEN CONTAMINATED WITH FUNGUS FOR THE SECOND TIME IN ONE MONTH. A SEPARATE SAMPLE FROM ANOTHER PATIENT HAD ALSO BECOME CONTAMINATED DURING EGD (ESOPHAGOGASTRODUODENOSCOPY) COLLECTION. THE PATHOLOGIST WONDERED IF THE SAID CONTAMINATION MIGHT BE COMING FROM THE SCOPE. THERE WERE NO REPORTS OF PATIENT HARM.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1594371 EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS AIZU OLYMPUS CO., LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown