BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLONOVIDEOSCOPE

    MDR report key: 16980700 · Received May 22, 2023

    Report

    Report Number
    9610595-2023-07844
    Event Type
    Malfunction
    Date Received
    May 22, 2023
    Report Date
    July 17, 2023
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED AND EVALUATED BY OLYMPUS. IN ADDITION TO THE FINDINGS IN B5, EVALUATION FOUND THE FOLLOWING ISSUES: A) FLEXIBILITY ADJUSTMENT RING HAS A SCRATCH, B) RIP HAS A SCRATCH, C) SWITCH BOX HAS A SCRATCH, D) SUCTION CYLINDER HAS DISCOLORATION, E) SCOPE CONNECTOR CASE UNIT HAS A SCRATCH, F) SCOPE CONNECTOR COVER UNIT HAS A SCRATCH, G) ELECTRICAL CONTACT OF ENDOSCOPE CONNECTOR HAS A SCRATCH, H) DUE TO CLOGGING OF NOZZLE, WATER SUPPLY VOLUME DOES NOT MEET THE STANDARD VALUE, I) DUE TO WEAR OF ANGLE WIRE, THE PLAY OF UPWARD/DOWNWARD ANGULATION CONTROL KNOB IS OUT OF THE STANDARD VALUE, J) PLASTIC DISTAL END COVER HAS A DENT, K) OBJECTIVE LENS HAS A SCRATCH, AND L) ADHESIVE ON BENDING SECTION COVER OR DISTAL SHEATH IS DETACHED. THIS EVENT IS UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON RECEIVING ADDITIONAL INFORMATION.

    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 FOREIGN MATERIAL OBSERVED IN THE CLOGGED NOZZLE APPEARED TO BE BLACK RUBBER MIXED WITH PLASTIC FIBERS BUT OTHERWISE COULD NOT BE IDENTIFIED. A DEFINITIVE ROOT CAUSE OF THE ISSUE COULD NOT BE DETERMINED, AS THERE WAS NO DEVICE DEFORMATION THAT MIGHT CONTRIBUTE TO THE RETENTION OF FOREIGN MATERIAL AND IT IS UNKNOWN IF THE FACILITY DEVICE REPROCESSING WAS IMPLEMENTED IN ACCORDANCE WITH THE IFU, HOWEVER, THE ISSUE WAS LIKELY THE RESULT OF INSUFFICIENT CLEANING. THE EVENT MAY BE DETECTED BY FOLLOWING THE INSTRUCTIONS FOR USE SECTION BELOW: -INSPECTION OF THE ENDOSCOPIC SYSTEM. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE AIR/WATER CHANNEL OF THE COLONOVIDEOSCOPE WAS CLOGGED. THE DEVICE WAS NOT REPROCESSED PRIOR TO BEING RETURNED FOR REPAIR DUE TO THE CLOGGED CHANNEL. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT. DURING DEVICE EVALUATION AT OLYMPUS, IT WAS FOUND THE COMPLAINT WAS CONFIRMED AND THE NOZZLE WAS CLOGGED WITH FOREIGN MATERIAL. THE FOREIGN MATERIAL WAS A BLACK RUBBER MIXED WITH PLASTIC FIBERS. THE REPORT IS BEING SUBMITTED DUE TO FOREIGN MATERIAL FOUND DURING EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829672 COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF AIZU OLYMPUS CO., LTD. CF-EZ1500DL

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown