BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II COLONOVIDEOSCOPE

    MDR report key: 19059623 · Received April 8, 2024

    Report

    Report Number
    9610595-2024-07247
    Event Type
    Malfunction
    Date Received
    April 8, 2024
    Report Date
    April 25, 2024
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDF
    UDI-DI
    04953170202315
    PMA / PMN Number
    K100584
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE EVALUATION IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. NEW INFORMATION ADDED TO THE FOLLOWING FIELDS: H3 AND H6. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER SEVENTEEN (17) YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, IT IS LIKELY THAT THE UNSPECIFIED FOREIGN MATERIAL AT DISTAL END OCCURRED BECAUSE THE REPROCESSING COULD NOT BE CONDUCTED PROPERLY DUE TO LEAKAGE FROM THE BENDING SECTION COVER. THE SUGGESTED EVENT IS DETECTABLE/PREVENTABLE BY HANDLING THE DEVICE IN ACCORDANCE WITH THE FOLLOWING INSTRUCTIONS FOR USE: INSTRUCTIONS FOR USE STATES THE DETECTION METHOD IN EVIS EXERA II GIF/CF/PCF TYPE 180 SERIES OPERATION MANUAL CHAPTER 3 PREPARATION AND INSPECTION. INSTRUCTIONS FOR USE STATES THE PREVENTATIVE MEASURES IN EVIS EXERA II GIF/CF/PCF TYPE 180 SERIES REPROCESSING MANUAL CHAPTER 5 REPROCESSING THE ENDOSCOPE (AND RELATED REPROCESSING ACCESSORIES). OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE COLONOVIDEOSCOPE EXHIBITED THE PLASTIC DISTAL END COVER HAS FOREIGN OBJECTS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417552 EVIS EXERA II COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF AIZU OLYMPUS CO., LTD. CF-Q180AL 04953170202315

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown