BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA ELITE COLONOVIDEOSCOPE

    MDR report key: 16904545 · Received May 10, 2023

    Report

    Report Number
    9610595-2023-07306
    Event Type
    Malfunction
    Date Received
    May 10, 2023
    Date of Event
    April 20, 2023
    Report Date
    June 9, 2023
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S INVESTIGATION AND CORRECTION TO B3. 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 OF THE FOREIGN MATERIAL WAS INSUFFICIENT CLEANING. IDENTIFICATION OF THE MATERIAL COULD NOT BE DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION AND THE CUSTOMER'S ALLEGATION WAS CONFIRMED. THE DEVICE EVALUATION FOUND THE FOLLOWING: A) SWITCH 1 IS DAMAGED, B) CONTROL SECTION HAS FOREIGN OBJECTS, C) DUE TO DAMAGE ON SWITCH1, WATER TIGHTNESS IS LOST, D) CONNECTING TUBE HAS A SCRATCH, E) DISTAL END IS DEFORMED, F) PLASTIC DISTAL END COVER HAS A BURN, G) ADHESIVE AROUND LIGHT GUIDE LENS IS PEELED, H) LIGHT GUIDE LENS HAS A CRACK, I) ADHESIVE AROUND OBJECTIVE LENS IS PEELED, J) MOUTHPIECE IS LOOSE, K) SWITCH3 HAS WEAR, K) SWITCH3 HAS A SCRATCH, L) SWITCH2 HAS A SCRATCH, M) SWITCH1 IS DEFORMED, N) PAINT ON SUCTION CYLINDER IS PEELED, O) PAINT ON AIR/WATER CYLINDER IS PEELED, P) ADHESIVE ON BENDING SECTION COVER OR DISTAL SHEATH RUBBER HAS A CRACK, R) ADHESIVE ON BENDING SECTION COVER OR DISTAL SHEATH RUBBER HAS A CHIP, S) DUE TO WEAR OF ANGLE WIRE, THE PLAY OF UPWARD/DOWNWARD ANGULATION CONTROL KNOB IS OUT OF THE STANDARD VALUE, T) DUE TO WEAR OF ANGLE WIRE, THE PLAY OF UPWARD/DOWNWARD ANGULATION CONTROL KNOB IS OUT OF THE STANDARD VALUE, U) DUE TO WEAR OF ANGLE WIRE, BENDING ANGLE IN UPWARD DIRECTION DOES NOT MEET THE STANDARD VALUE, V) DUE TO ADHESIVE PEELING AROUND OBJECTIVE LENS, STREAK OF FLARE APPEARS IN THE IMAGE W) DUE TO DAMAGE, SWITCH1 DOES NOT WORK, X) UNIVERSAL CORD HAS A WRINKLE, Y) UNIVERSAL CORD HAS A SCRATCH AND Z) SUE TO A SCRATCH ON OBJECTIVE LENS FLARE OCCURS. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE BUTTON OF THE EVIS LUCERA ELITE COLONOVIDEOSCOPE WAS COMING OFF. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. THE SUBJECT DEVICE WAS SUBSEQUENTLY EVALUATED BY OLYMPUS. THE EVALUATION UNCOVERED THAT THE CONTROL SECTION HAS FOREIGN OBJECTS. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE MALFUNCTION FOUND DURING THE EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    882351 EVIS LUCERA ELITE COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF AIZU OLYMPUS CO., LTD. PCF-H290I

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown