BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS LUCERA ELITE DUODENOVIDEOSCOPE

    MDR report key: 16232808 · Received January 24, 2023

    Report

    Report Number
    9610595-2023-01199
    Event Type
    Injury
    Date Received
    January 24, 2023
    Date of Event
    September 18, 2019
    Report Date
    January 24, 2023
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SERIAL NUMBER OF THE DEVICE REFERENCED IN THIS REPORT WAS NOT REPORTED; THEREFORE, IT IS UNKNOWN IF THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION OR NOT. THE MANUFACTURING DATE OF THE DEVICE CANNOT BE DETERMINED , AS THE SERIAL NUMBER IS UNKNOWN. THE DEVICE HISTORY RECORD WAS UNABLE TO BE REVIEWED. HOWEVER, OLYMPUS ONLY RELEASES PRODUCTS TO MARKET THAT MEET ALL MANUFACTURING SPECIFICATIONS AND FINAL PRODUCT RELEASE CRITERIA. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, THE FOLLOWING ARE THE MOST LIKELY CAUSE OF THE REPORTED EVENT: (1) THE DISTAL END COVER WAS INAPPROPRIATELY ATTACHED TO THE ENDOSCOPE. (2) DISTAL END COVER A CRACK AND/ OR PINHOLE. (3) CHEMICAL SOLUTIONS SUCH AS ANTI-FOG AGENT ADHERED TO THE DISTAL END COVER, WHICH CAUSE THE DISTAL END COVER TO BREAK. THE DEVICE INSTRUCTION MANUAL INCLUDES THE FOLLOWING CAUTION AND WARNING STATEMENTS: ¿NEVER USE A SINGLE USE DISTAL COVER WITH CRACKS OR PINHOLES. REPLACE IT WITH A NEW ONE. IF A SINGLE USE DISTAL COVER WITH CRACKS OR PINHOLES IS USED, IT COULD FALL OFF DURING THE EXAMINATION AND/OR, IT MAY CAUSE THERMAL INJURY DUE TO ELECTRIC CURRENT LEAKS FROM CRACKS OR PINHOLES WHEN HIGH-FREQUENCY CAUTERIZATION TREATMENT IS PERFORMED. ALSO, USING THE SINGLE USE DISTAL COVER WITH CRACKS MAY CAUSE PATIENT INJURY DUE TO SHARP EDGES." "INSPECTION OF ACCESSORIES: INSPECTION OF THE SINGLE USE DISTAL COVER (MAJ-2315): SHOULD ANY IRREGULARITY BE OBSERVED WHEN INSPECTING THE SINGLE USE DISTAL COVER, DO NOT USE IT. A SINGLE USE DISTAL COVER WITH IRREGULARITY COULD NOT SERVE THE ENDOSCOPE PROPERLY AND/OR COULD FALL OFF DURING THE EXAMINATION. USING THE ENDOSCOPE WITHOUT THE SINGLE USE DISTAL COVER COULD CAUSE PATIENT INJURY AND THIS COULD RESULT IN THERMAL INJURY WHEN THE ENDOSCOPE IS USED WITH HIGH-FREQUENCY ENDOTHERAPY ACCESSORIES. IN ADDITION, IF THE SINGLE USE DISTAL COVER FALLS OFF IN THE ORAL CAVITY, IT MAY CAUSE ASPIRATION OR RESPIRATORY DISTRESS IF NOT PROMPTLY IDENTIFIED AND REMOVED." ATTACHING ACCESSORIES TO THE ENDOSCOPE: ATTACHING THE SINGLE USE DISTAL COVER: ¿DO NOT APPLY ANTI-FOGGING PRODUCTS, OLIVE OIL, OR PRODUCTS CONTAINING PETROLEUM-BASED SUBSTANCES (E.G., VASELINE®) TO THE SINGLE USE DISTAL COVER OR THE ENDOSCOPE. THESE PRODUCTS MAY CAUSE CRACKS IN THE SINGLE USE DISTAL COVER. IF A SINGLE USE DISTAL COVER WITH CRACKS IS USED, IT MAY CAUSE PATIENT INJURY SUCH AS: THERMAL INJURY FROM ELECTRIC CURRENT LEAKS WHEN PERFORMING HIGH-FREQUENCY CAUTERIZATION TREATMENT. / DAMAGE OR CUTS TO THE MUCOSAL MEMBRANE FROM SHARP EDGES DUE TO THE CRACKS ON THE SINGLE USE DISTAL COVER. - DETACH THE SINGLE USE DISTAL COVER FROM THE DISTAL END OF THE ENDOSCOPE WHEN THE SINGLE USE DISTAL COVER CANNOT BE ATTACHED TO THE ENDOSCOPE SMOOTHLY OR ANY INCORRECT ATTACHING PROCEDURE IS NOTICED. IF THE SINGLE USE DISTAL COVER IS NOT ATTACHED PROPERLY, IT MAY SLIP OFF OR FALL OFF THE DISTAL END DURING THE EXAMINATION. THIS COULD RESULT IN THERMAL INJURY WHEN THE ENDOSCOPE IS USED WITH HIGH-FREQUENCY ENDOTHERAPY ACCESSORIES.¿ THE DISTAL END COVER HAS A LOT NUMBER OF H8X24, WHICH IS DETERMINED TO BE MANUFACTURED PRIOR TO THE DESIGN CHANGE. INVESTIGATION ACTIVITIES HAVE BEEN OPENED TO MANAGE THE ACTIONS RELATED TO THIS REPORT AND ANY REQUIRED MDR REPORTING.

    Description of Event or Problem · 0

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE SINGLE USE DISTAL END COVER WAS FOUND MISSING WHEN THE SCOPE AND DRAINAGE TUBE WAS BEING WITHDRAWN FROM THE PATIENT . THE USER PRESUMED THAT THE DISTAL END COVER BECAME DETACHED FROM THE DUODENOSCOPE AND FELL INTO TO THE PATIENT'S BODY. THE TIMING OF THE DETACHMENT IS UNKNOWN, AND THE DISTAL END COVER WAS THOUGHT TO HAVE REMAINED IN THE PATIENT'S BODY. THE INTENDED PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WAS NO REPORTED HEALTH DAMAGE TO THE PATIENT. THIS REPORT IS RELATED TO COMPLAINT NUMBER (B)(4), WHICH WAS REPORTED UNDER MDR NUMBER 8010047 - 2019 ¿ 03602.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689337 EVIS LUCERA ELITE DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT AIZU OLYMPUS CO., LTD. TJF-Q290V

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male MAJ-2315 WITH LOT NUMBER H8X24