BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLONOVIDEOSCOPE

    MDR report key: 17715653 · Received September 8, 2023

    Report

    Report Number
    9610595-2023-13009
    Event Type
    Malfunction
    Date Received
    September 8, 2023
    Report Date
    October 3, 2023
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDF
    UDI-DI
    04953170424281
    PMA / PMN Number
    K222584
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR A DEVICE EVALUATION AND THE CUSTOMER¿S ALLEGATION WAS CONFIRMED. IN ADDITION TO THE REPORTED IN B5, THE DEVICE EVALUATION FOUND THE FOLLOWING: THE SUCTION CYLINDER HAD NO COLOR, THE SCREW STOPPER WAS REPLACED FOR PREVENTIVE MAINTENANCE, DUE TO WEAR OF THE ANGLE WIRE THE PLAY OF THE RIGHT/LEFT KNOB WAS OUT OF THE STANDARD VALUE, THE IMAGE GUIDE PROTECTOR WAS DAMAGED, THE PLASTIC DISTAL END COVER HAD A SCRATCH, THE ADHESIVE AROUND THE OBJECTIVE LENS HAD DISCOLORATION, THE ADHESIVE AROUND THE LIGHT GUIDE LENS HAD DISCOLORATION, THE ADHESIVE ON THE BENDING SECTION COVER RUBBER HAD A CRACK, THE CONNECTING TUBE HAD A CUT, AND THE UNIVERSAL CORD HAD BUCKLING. THE CUSTOMER FLUSHED THE DEVICE WITH AIR, WATER, AND DETERGENT DURING A MANUAL CLEANING BEFORE RETURNING TO OLYMPUS. THE INVESTIGATION IS ONGOING, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED.

    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 DEFORMATION OF THE NOZZLE WAS OBSERVED, NOR WAS ANY OBVIOUS DEVIATION OF REPROCESSING. THEREFORE, THE CAUSE OF THE REMAINING FOREIGN MATERIAL COULD NOT BE PRESUMED FROM THE OBTAINED INFORMATION. THE SUGGESTED EVENT IS DETECTABLE/PREVENTABLE BY HANDLING THE DEVICE IN ACCORDANCE WITH THE FOLLOWING INSTRUCTIONS FOR USE (IFU): IFU STATES THE DETECTION METHOD IN CF-HQ1100DL/I OPERATION MANUAL CHAPTER 3 PREPARATION AND INSPECTION IFU STATES THE PREVENTATIVE MEASURES IN CF-HQ1100DL/I REPROCESSING MANUAL CHAPTER 5 REPROCESSING THE ENDOSCOPE OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS THAT THE COLONOVIDEOSCOPE LEFT/RIGHT KNOB HAD A LOT OF SLACK. THE ISSUE WAS OBSERVED DURING A THERAPEUTIC PROCEDURE. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE WITH NO REPORTS OF PATIENT OR USER HARM ASSOCIATED. THE DEVICE WAS RETURNED TO OLYMPUS FOR A DEVICE EVALUATION AND FOUND THE AIR/WATER TUBE AND CYLINDER HAD FOREIGN MATERIAL ATTACHED. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525424 COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF AIZU OLYMPUS CO., LTD. CF-HQ1100DL 04953170424281

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown