BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA COLONOVIDEOSCOPE

    MDR report key: 16846554 · Received May 1, 2023

    Report

    Report Number
    9610595-2023-06935
    Event Type
    Malfunction
    Date Received
    May 1, 2023
    Date of Event
    April 3, 2023
    Report Date
    June 9, 2023
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION, AND TO CORRECT INFORMATION FOUND IN THE INITIAL REPORT. BASED ON THE RESULTS OF THE LEGAL MANUFACTURER'S INVESTIGATION, THE SUGGESTED EVENT ¿WHITE REMNANTS IN A/W CHANNEL¿ WAS CONFIRMED, AND THE SPECIFICATIONS AND FUNCTIONS WERE NOT SATISFIED. THE FOREIGN MATERIAL WAS FOUND TO BE INFACOL (SIMETHICONE). IT WAS LIKELY THAT FOREIGN MATERIAL REMAINED DUE TO DEVIATION FROM IFU IN USER HANDLING. HOWEVER, IT WAS CONFIRMED THAT BY THE REPORTS: "054-0015, 054-0013, 054-0007, 060-3813, 060-4003, AND 066-3255" THAT PERFORMANCE OF REPROCESSING ON THE DEVICE IS SECURED BY REPROCESSING IN ACCORDANCE WITH IFU. (CLEANING/DISINFECTION/STERILIZATION). THERE WAS NO PHYSICAL DAMAGE AT THE POINT WHERE FOREIGN MATERIAL WAS DETECTED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 11 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. THE SUGGESTED EVENT IS DETECTABLE AND PREVENTABLE BY HANDLING THE DEVICE IN ACCORDANCE WITH THE FOLLOWING IFU: EVIS LUCERA GIF/CF/PCF TYPE 260 SERIES OPERATION MANUAL INCLUDES THE DETECTION WAY IN CHAPTER 3 PREPARATION AND INSPECTION. EVIS LUCERA GIF/CF/PCF TYPE 260 SERIES OPERATION MANUAL INCLUDES THE PREVENTIVE MEASURES IN 3.6 INSPECTION OF THE ENDOSCOPIC SYSTEM: NOTHING OTHER THAN STERILE WATER SHOULD BE USED FOR AIR/WATER FEEDING. NO ADDITIVES SHOULD BE PUT INTO THE STERILE WATER. NON-STERILE WATER MAY CAUSE PATIENT CROSS-CONTAMINATION AND/OR INFECTION. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION. THE CUSTOMERS¿ ALLEGATION WAS CONFIRMED. REMNANTS OF WHITE CRYSTALLIZED CONTAMINATION BELIEVED TO BE AN INFACOL (SIMETHICONE) TYPE PRODUCT, WAS EVIDENT WITHIN THE AIR AND WATER CHANNELS. ADDITIONAL EVENTS ARE AS FOLLOWS: A.) THE LIGHT COVER GLASSES WERE CHIPPED. (B.) THE LIGHT COVER ADHESIVE WERE WORN. (C.) THE DISTAL END ADHESIVE EDGE FAILED. (D.) THE CONTROL BODY FAILED ASPIRATION RING WAS DAMAGED. (E.) THE CONTROL BODY OR THE AIR/WATER HOUSING RING FAILED FROM RING DAMAGE. (F.) THE CHARGED COUPLED DEVICE WIRE LENGTH WAS TOO SHORT. (G.) THE UP/DOWN ANGLE FAILED AND WAS INOPERATIVE. (H.) AND THE ELECTRICAL SAFETY TEST FAILED. 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

    THE CUSTOMER REPORTED TO OLYMPUS, THE EVIS LUCERA COLONOVIDEOSCOPE HAD ISSUES WITH THE FAULT IN THE ANGULATION SYSTEM. THE EVENT TOOK PLACE DURING MAINTENANCE. THERE WAS NO HEALTH HAZARD TO THE PATIENT OR USER OF THE DEVICE. THE SUBJECT DEVICE WAS SUBSEQUENTLY EVALUATED BY OLYMPUS, AND CONFIRMED DURING THE INITIAL INSPECTION OF THE DEVICE, THERE WAS WHITE CONTAMINATION EVIDENT IN THE AIR AND WATER CHANNELS. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING THE EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702423 EVIS LUCERA COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF AIZU OLYMPUS CO., LTD. CF-Q260DL

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown