BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA ELITE GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 17435491 · Received August 1, 2023

    Report

    Report Number
    9610595-2023-10907
    Event Type
    Malfunction
    Date Received
    August 1, 2023
    Report Date
    August 1, 2023
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION. THE CUSTOMER'S ALLEGATION OF THE CLOUDY IMAGE WAS CONFIRMED DUE TO DAMAGE ON THE CHARGED CABLED DEVICE UNIT. IT WAS ALSO DISCOVERED THAT THERE WAS FOREIGN MATTER FOUND WITHIN THE NOZZLE DUE TO INSUFFICIENT CLEANING. ADDITIONALLY THE FOLLOWING EVENTS WERE IDENTIFIED AND ARE AS FOLLOWS: (A.) DUE TO DEFORMATION OF SCOPE CONNECTOR COVER (S-COVER), WATER TIGHTNESS IS LOST, (B.) THE CONNECTING TUBE HAD DISCOLORATION, (C.) THE CONNECTING TUBE HAD A SCRATCH, (D.) THE CONNECTING TUBE HAD A DENT, (E.) ADHESIVE AROUND THE OBJECTIVE LENS WAS PEELED, (F.) THE OBJECTIVE LENS HAD A CHIP, (G.) THE S-COVER HAS DISCOLORATION, (H.) THE CONNECTING TUBE HAD A WRINKLE, (I.) THE S-COVER HAD A SCRATCH, (J.) DUE TO CLOGGING OF THE NOZZLE THE WATER SUPPLY VOLUME DID NOT MEET THE STANDARD VALUE, (K.) DUE TO CLOGGING OF THE NOZZLE, AIR SUPPLY DID NOT MEET THE STANDARD VALUE, (L.) ADHESIVE ON BENDING SECTION COVER, (A-RUBBER) HAS A CHIP, (M.) THE A-RUBBER HAD A SCRATCH, (N.) DUE TO WEAR OF ANGLE WIRE, THE PLAY OF UP/DOWN (U/D) KNOB IS OUT OF THE STANDARD VALUE, (O.) DUE TO WEAR OF ANGLE WIRE, BENDING ANGLE IN UP DIRECTION DOES NOT MEET THE STANDARD VALUE, (P.) DUE TO A SCRATCH ON A-RUBBER, INSULATION RESISTANCE VALUE AT DISTAL END DOES NOT MEET THE STANDARD VALUE, (Q.) DUE TO ADHESIVE PEELING AROUND OBJECTIVE LENS, STREAK OF FLARE APPEARS IN THE IMAGE, (R.) THE UNIVERSAL CORD HAD DISCOLORATION, (S.) THE UNIVERSAL CORD HAD A SCRATCH, (T.) THE FORCEPS CHANNEL PORT WAS SHAVED, (U.) THE GRIP HAD A SCRATCH, (V.) THE LOCK ENGAGEMENT LEVER HAD DISCOLORATION, (W.) THE RIGHT/ LEFT KNOB HAD DISCOLORATION, (X.) THE SWITCH BUTTON 4 HAD WEAR, (Y.) THE SWITCH BOX HAD DISCOLORATION, (Z.) AND THE CONTROL UNIT HAD DISCOLORATION. 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, A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS THAT THE EVIS LUCERA ELITE GASTROINTESTINAL VIDEOSCOPE EXPERIENCED A CLOUDY IMAGE. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. THERE WAS NO PATIENT INVOLVEMENT, THEREFORE, WAS NO REPORT OF PATIENT OR USER HARM ASSOCIATED WITH THE EVENT. SUBSEQUENTLY THE DEVICE WAS RETURNED FOR EVALUATION, AND IT WAS DISCOVERED THAT THERE WAS FOREIGN MATTER FOUND WITHIN THE NOZZLE. THIS MEDWATCH REPORT IS BEING SUBMITTED TO CAPTURE THIS REPORTABLE MALFUNCTION WHICH WAS IDENTIFIED DURING THE EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2335274 EVIS LUCERA ELITE GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS AIZU OLYMPUS CO., LTD. GIF-XP290N

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown