BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLONOVIDEOSCOPE

    MDR report key: 18414074 · Received December 28, 2023

    Report

    Report Number
    9610595-2023-20531
    Event Type
    Malfunction
    Date Received
    December 28, 2023
    Report Date
    January 24, 2024
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    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, A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED. THE SUGGESTED PHENOMENON WAS CONFIRMED - HOWEVER, THE FOREIGN MATERIAL IN THE NOZZLE WAS UNABLE TO BE FURTHER SPECIFIED. MOREOVER, NO PHYSICAL DAMAGE OF THE DEVICE WAS CONFIRMED WHERE THE FOREIGN MATERIAL HAD REMAINED, NOR WAS ANY OBVIOUS DEVIATION OF REPROCESSING. THEREFORE, THE CAUSE OF THE REMAINING FOREIGN MATERIAL COULD NOT BE PRESUMED FROM THE OBTAINED INFORMATION. IT IS SUGGESTED THAT THE USER FACILITY REVIEW THE METHOD OF REPROCESSING FOR THE DEVICE ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE EVENT CAN BE DETECTED AND PREVENTED IN ACCORDANCE WITH THE FOLLOWING IFU: IFU STATES THAT DETECTION METHOD IN G CF-EZ1500DL/I OPERATION MANUAL CHAPTER 3 PREPARATION AND INSPECTION. IFU STATES THAT PREVENTIVE MEASURE IN CF-EZ1500DL/I REPROCESSING MANUAL CHAPTER 5 REPROCESSING THE ENDOSCOPE (AND RELATED REPROCESSING ACCESSORIES). OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED AS PART OF THE ASSET RETURN PROCESS, THE EVALUATION FOUND: THE BENDING SECTION COVER, CONNECTING TUBE, AND UNIVERSAL CORD HAD A SCRATCH; ADHESIVES AROUND THE OBJECTIVE LENS HAD WHITE-CLOUDED AREA; ADHESIVES AROUND THE LIGHT GUIDE LENS HAD WHITE-CLOUDED AREA; THERE WERE NO ELECTRICAL CONTINUITY DUE TO DAMAGE ON DISTAL END; ADHESIVE ON BENDING SECTION COVER HAD A CHIP AND WHITE-CLOUDED AREA; SWITCH BOX HAD A CRACK; AND THE GRIP WAS SHAVED. DUE TO WEAR OF ANGLE WIRE, THE BENDING ANGLE IN UP DIRECTION DOES NOT MEET THE STANDARD VALUE. DUE TO WEAR OF ANGLE WIRE, THE PLAY OF UP/DOWN KNOB IS OUT OF THE STANDARD VALUE. DUE TO CLOGGING OF NOZZLE, THE WATER REMOVAL ABILITY DOES NOT MEET THE STANDARD VALUE. THE CLEANING, DISINFECTION, AND STERILIZATION (CDS) WAS PERFORMED BY THE CUSTOMER BEFORE IT WAS SENT BACK TO OLYMPUS FOR REPAIR, THE CUSTOMER DID NOT KNOW WHEN THE FOREIGN MATERIAL MAY HAVE ADHERED TO THE ENDOSCOPE OR WHAT THE MATERIAL MAY BE. IT WAS UNKNOWN IF THERE WAS ANY DELAY IN THE START OF PRECLEANING. THE CUSTOMER FLUSHED THE AIR/WATER NOZZLE WITH WATER AND AIR. THERE WERE NO ABNORMALITIES IN THE ACCESSORIES USED FOR REPROCESSING. IT WAS UNKNOWN WHETHER THE CUSTOMER PRESOAKED THE ENDOSCOPE IN THE DETERGENT SOLUTION. IT WAS UNKNOWN WHETHER THE CUSTOMER WIPED/BRUSHED THE AIR/WATER NOZZLE WITH CLEAN LINT-FREE CLOTHS, BRUSHES OR SPONGES. THE CUSTOMER FLUSHED THE AIR/WATER NOZZLE WITH THE DETERGENT SOLUTION. THERE WERE NO PARTICULAR CONCERNS AS CLEANING AND DISINFECTION WAS CARRIED OUT WITH THE ENDOSCOPE REPROCESSOR. THE INVESTIGATION IS ONGOING, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED.

    Description of Event or Problem · 0

    A USER FACILITY RETURNED THE OLYMPUS ASSET, COLONOVIDEOSCOPE, TO THE OLYMPUS SERVICE CENTER. UPON INSPECTION AND TESTING OF THE RETURNED DEVICE, IT WAS OBSERVED THAT THE NOZZLE HAD FOREIGN MATERIAL DUE TO INSUFFICIENT CLEANING. THIS REPORT IS BEING SUBMITTED FOR THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1400954 COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF AIZU OLYMPUS CO., LTD. CF-EZ1500DI

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown