BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III COLONOVIDEOSCOPE

    MDR report key: 16827865 · Received April 27, 2023

    Report

    Report Number
    9610595-2023-06837
    Event Type
    Malfunction
    Date Received
    April 27, 2023
    Date of Event
    March 30, 2023
    Report Date
    June 9, 2023
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDF
    UDI-DI
    04953170305191
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. BASED ON THE RESULTS OF THE LEGAL MANUFACTURER'S INVESTIGATION, THE SUGGESTED EVENT ¿FOREIGN MATERIAL CLOGGED IN THE A/W CHANNEL¿ WAS CONFIRMED, AND THE SPECIFICATIONS AND FUNCTIONS WERE NOT SATISFIED. THE FOREIGN MATERIAL COULD NOT BE IDENTIFIED AS WELL AS THE CAUSE OF THE RESIDUAL FOREIGN MATERIAL. ADDITIONALLY, IT WAS CONFIRMED THAT REPROCESSING WAS CONDUCTED IN ACCORDANCE WITH IFU AND WAS CONFIRMED BY THE REPORTS: 962-0180, 962-0179, 062-3555, 066-3255 THAT PERFORMANCE OF REPROCESSING ON THE DEVICE IS SECURED BY REPROCESSING IN ACCORDANCE WITH IFU. (CLEANING/ DISINFECTION/ STERILIZATION). A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 8 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. THE SUGGESTED EVENT IS DETECTABLE/PREVENTABLE BY HANDLING THE DEVICE IN ACCORDANCE WITH THE FOLLOWING IFU: IFU STATES THE DETECTION METHOD IN GIF/CF/PCF-190 SERIES OPERATION MANUAL CHAPTER 3 PREPARATION AND INSPECTION. IFU STATES THE PREVENTATIVE MEASURES IN GIF/CF/PCF-190 SERIES REPROCESSING MANUAL CHAPTER 5 REPROCESSING THE ENDOSCOPE. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION. DURING INSPECTION AND TESTING, THE ALLEGATION WAS CONFIRMED. THERE WAS NO FLOW DUE TO A CLOGGED NOZZLE. IN ADDITION TO EVALUATION IN B5, THE PLASTIC DISTAL END COVER HAD MINOR SCRATCHES. THE OBJECTIVE LENS HAD MINOR SCRATCHES, NOT AFFECTING THE IMAGE. THE OBJECTIVE LENS HAD TINY CHIPS. THE BENDING SECTION COVER HAD A DEEP SCRATCH. THE INVESTIGATION IS ONGOING AND FOLLOW UP WITH THE USER FACILITY IS CURRENTLY BEING PERFORMED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED TO OLYMPUS, THE EVIS EXERA III COLONOVIDEOSCOPE HAD NO FLOW FROM THE MAIN AIR/WATER SYSTEM (BLOCKED WATER CHANNEL). THE EVENT WAS FOUND DURING REPROCESSING. THERE WAS NO REPORT OF PATIENT HARM. DURING INCOMING INSPECTION, FOREIGN MATTER CLOGGED THE NOZZLE DUE TO INSUFFICIENT REPROCESSING. THIS MEDWATCH IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465867 EVIS EXERA III COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF AIZU OLYMPUS CO., LTD. PCF-H190L 04953170305191

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown