BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA ELITE COLONOVIDEOSCOPE

    MDR report key: 13907826 · Received March 25, 2022

    Report

    Report Number
    8010047-2022-05081
    Event Type
    Malfunction
    Date Received
    March 25, 2022
    Report Date
    May 27, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE WAS RETURNED TO OLYMPUS AND EVALUATED. THE EVALUATION DID NOT REPRODUCE THE REPORTED PROBLEM OF "E315" ERROR. THE INVESTIGATION IS ONGOING AND THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY. THE EVALUATION FOUND THE FOLLOWING: ANGULATION IN THE UP DIRECTION IS OUT OF STANDARDS DUE TO WORN OF ANGLE-WIRE. THE GAP OF U/D KNOB IS OUT OF STANDARDS DUE TO WORN OF ANGLE-WIRE. INSERTION QUANTITY IS OUT OF STANDARDS DUE TO DAMAGE OF CHANNEL TUBE. LIQUID LEASKS DUE TO SCRATCH OF DISTAL-END. LIQUID LEAKS DUE TO PERFORATION OF CHANNEL TUBE. THE CONDITION OF LG-BUNDLE IS NOT GOOD. THERE IS GAP AT THE ADHESIVE PART OF AR. THERE IS CORROSION AT THE SC COVER UNIT DUE TO LEAKAGE. (B)(6) LENS HAS SCRATCHES. INVESTIGATION ACTIVITIES HAVE BEEN OPENED TO MANAGE THE ACTIONS RELATED TO THIS ISSUE AND ANY REQUIRED MDR REPORTING.

    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, THE LEAKAGE OCCURRED BY USER HANDLING THE DEVICE WHICH WATER ENTERED AND DAMAGED THE ELECTRICAL COMPONENTS. THE SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED AT THIS TIME. USERS MAY PREVENT THE SUGGESTED EVENT BY HANDLING THE DEVICE IN ACCORDANCE WITH THE FOLLOWING THE INSTRUCTIONS FOR USE: "WHEN INSERTING OR WITHDRAWING AN ENDOTHERAPY ACCESSORY, CONFIRM THAT ITS DISTAL END IS CLOSED OR COMPLETELY RETRACTED INTO THE SHEATH. SLOWLY INSERT OR WITHDRAW THE ENDOTHERAPY ACCESSORY STRAIGHT INTO OR FROM THE SLIT OF THE BIOPSY VALVE. OTHERWISE, THE BIOPSY VALVE OR INSTRUMENT CHANNEL MAY BE DAMAGED AND PIECES OF IT COULD FALL OFF. IT MAY CAUSE PATIENT INJURY. IF INSERTION OR WITHDRAWAL OF ENDOTHERAPY ACCESSORIES IS DIFFICULT, STRAIGHTEN THE BENDING SECTION AS MUCH AS POSSIBLE WITHOUT LOSING THE ENDOSCOPIC IMAGE. INSERTING OR WITHDRAWING ENDOTHERAPY ACCESSORIES WITH EXCESSIVE FORCE MAY DAMAGE THE INSTRUMENT CHANNEL OR ENDOTHERAPY ACCESSORIES AND COULD CAUSE SOME PARTS TO FALL OFF AND/OR CAUSE PATIENT INJURY. IF THE DISTAL END OF AN ENDOTHERAPY ACCESSORY IS NOT VISIBLE IN THE ENDOSCOPIC IMAGE, DO NOT OPEN THE DISTAL END OR EXTEND THE NEEDLE OF THE ENDOTHERAPY ACCESSORY. THIS COULD CAUSE PATIENT INJURY, BLEEDING, PERFORATION, AND/OR EQUIPMENT DAMAGE." OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    A USER FACILITY REPORTED TO OLYMPUS THAT ERROR "E315" OCCURRED. THE PROBLEM, AS REPORTED TO OLYMPUS, WAS IDENTIFIED DURING PREPARATION FOR USE. THERE WAS NO PATIENT INJURY, ASSOCIATED WITH THE PROBLEM, REPORTED TO OLYMPUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676290 EVIS LUCERA ELITE COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF OLYMPUS MEDICAL SYSTEMS CORP. CF-HQ290I

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown