BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA ELITE COLONOVIDEOSCOPE

    MDR report key: 16463796 · Received March 1, 2023

    Report

    Report Number
    9610595-2023-03527
    Event Type
    Malfunction
    Date Received
    March 1, 2023
    Report Date
    April 7, 2023
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION. THE CUSTOMER'S COMPLAINT WAS CONFIRMED, THE ERROR OCCURRED DUE TO CORROSION OF PLUG-UNIT. IN ADDITION TO THE FINDINGS REPORTED IN THE EVENT DESCRIPTION, THE FOLLOWING NON-REPORTABLE MALFUNCTIONS WERE IDENTIFIED: THE ANGULATION IN THE UP DIRECTION IS OUT OF SECTION DUE TO THE ANGLE WIRE IS WORN/AIR, WATER CYLINDER DAMAGED, DUE TO LEKS/CREASE AT THE COVER/LENS DIRTY AND BROKE/ADHESIVE RUBBER BROKEN, AND CORROSION ON VARIOUS PARTS OF THE DEVICE. THE INVESTIGATION IS PENDING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION, TO CORRECT E2/3, AND TO CORRECT G2 (COUNTRY IS SOUTH KOREA). 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, THE ROOT CAUSE COULD NOT BE DETERMINED. IT IS LIKELY WATER INVADED THE SCOPE CONNECTOR WHILE THE USER WAS HANDLING THE DEVICE, WHICH LED TO AN ABNORMALITY IN THE ELECTRICAL PARTS (CORRODED PLUG UNIT) AND RESULTED IN THE DISPLAYED ERROR MESSAGE (E315). THE EVENT CAN BE DETECTED AND PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE (IFU) WHICH STATE: "·INSPECTION OF THE ENDOSCOPIC IMAGE." "·WHEN ATTACHING THE CONNECTOR CAP OF THE LEAKAGE TESTER (MB-155) TO THE VENTING CONNECTOR OF THE ENDOSCOPE, MAKE SURE THAT BOTH THE CONNECTOR CAP AND THE VENTING CONNECTOR ARE THOROUGHLY DRY. WATER ON THE SURFACE OF EITHER COMPONENT MAY ENTER THE ENDOSCOPE AND COULD CAUSE ENDOSCOPE DAMAGE. ·DO NOT ATTACH/DETACH THE LEAKAGE TESTER WHILE THE ENDOSCOPE IS IMMERSED. ATTACHING/DETACHING UNDER WATER COULD ALLOW THE WATER TO ENTER THE ENDOSCOPE, RESULTING IN ENDOSCOPE DAMAGE. ·PERFORM A LEAKAGE TEST ON THE ENDOSCOPE AFTER EACH PRECLEANING PROCEDURE. DO NOT USE THE ENDOSCOPE IF A LEAK IS DETECTED. USE OF AN ENDOSCOPE WITH A LEAK MAY CAUSE A SUDDEN LOSS OF THE ENDOSCOPIC IMAGE, DAMAGE TO THE BENDING MECHANISM, OR OTHER MALFUNCTIONS. USE OF A LEAKING ENDOSCOPE MAY ALSO POSE AN INFECTION CONTROL RISK." OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS, THAT DURING FOR USE ON EVIS LUCERA ELITE COLONOVIDEOSCOPE FOR AN UNKNOWN DIAGNOSTIC PROCEDURE, ERROR CODE E315. THERE WAS NO DELAY, THE PROCEDURE WAS COMPLETED USING A SIMILAR SCOPE. THERE WAS NO PATIENT HARM ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1054793 EVIS LUCERA ELITE COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF AIZU OLYMPUS CO., LTD. CF-H290L

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown