BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 21937496 · Received April 30, 2025

    Report

    Report Number
    9610595-2025-07449
    Event Type
    Malfunction
    Date Received
    April 30, 2025
    Date of Event
    April 11, 2025
    Report Date
    November 10, 2025
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDS
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THAT THE FOLLOWING LED TO THE MALFUNCTION: THE PROBABLE CAUSE OF THE ISSUE WAS NOTED TO BE DUE TO FAILURE TO FOLLOW INSTRUCTIONS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO CORRECT AND UPDATE THE INFORMATION THAT WAS PREVIOUSLY SUBMITTED IN THE INITIAL REPORT. UPDATED FIELDS: D4, G4. CORRECTED FIELDS: D10, E1, E4, H6. THE INVESTIGATION CONCLUSION CODE FOR THE WHITE FOREIGN MATERIAL WAS UPDATED FROM D11/1101/1102 TO D15. IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION: THE FOREIGN MATERIAL WAS POSSIBLY NOT REMOVED COMPLETELY EVEN IF THE REPROCESSING STEPS WERE CONDUCTED PROPERLY. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE JET TUBE HAD FOREIGN OBJECTS. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1242385 GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS AIZU OLYMPUS CO., LTD. GIF-EZ1500 2304505

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown