BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA DUODENOVIDEOSCOPE

    MDR report key: 18297557 · Received December 8, 2023

    Report

    Report Number
    9610595-2023-19149
    Event Type
    Malfunction
    Date Received
    December 8, 2023
    Report Date
    January 10, 2024
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION AND THE EVALUATION FOUND THAT THE ANGULATION IN THE UP DIRECTION WAS OUT OF STANDARD DUE TO THE WORN ANGLE WIRE, THE CONNECTING TUBE PROTECTOR WAS BROKEN, A CORRODED ELECTRICAL CONNECTOR DUE TO A LEAKAGE, THE FORCEPS ELEVATOR DID NOT MOVE SMOOTHLY SINCE THE KNOB WIRE WAS CUT, WATERPROOF FAILURE DUE TO A DEFORMED FORCEPS LEVER, A WHITE SCRATCH ON THE IMAGE DUE TO A BROKEN CHARGED COUPLED DEVICE UNIT, A BROKEN CHARGED COUPLED DEVICE LENS, BENDING SECTION COVER ADHESIVE AND LIGHT GUIDE LENS, A DEFORMED SCOPE COVER, AND A CORRUGATED CONNECTING TUBE. THE INVESTIGATION IS ONGOING. 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

    B5: CUSTOMER ADDITIONALLY REPORTED THAT THE DEVICE WAS CLEANED, DISINFECTED, AND STERILIZED BEFORE IT WAS RETURNED TO OLYMPUS. IT WAS NOT KNOWN WHEN THE FOREIGN MATERIAL ADHERED TO THE ENDOSCOPE. THE ENDOSCOPE WAS NOT USED FOR THE PROCEDURE WITH THE FOREIGN MATERIAL ATTACHED. THERE WAS NO DELAY IN THE START OF PRECLEANING. THE AIR/WATER NOZZLE WAS FLUSHED WITH WATER AND AIR. NO ABNORMALITIES IN THE ACCESSORIES USED IN REPROCESSING. THE NOZZLE WAS WIPED/BRUSHED WITH A CLEAN LINT-FREE CLOTH/BRUSH/SPONGE. THE AIR/WATER NOZZLE WAS FLUSHED WITH DETERGENT. 3331, 4109, 202, 4228, 4315. THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S 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 ROOT CAUSE OF THE DISCOLORED LIGHT GUIDE LENS WAS HUMIDITY INVASION WHICH RESULTED FROM DEFECT OF THE SUBJECT DEVICE, OR CORROSION OF GLUE BETWEEN THE LG-LENS AND C-BODY RESULTED FROM DEGRADATION OF WATER TIGHTNESS ON THE OUTER SURFACE OF LG-LENS. LEAK OCCURRED AT THE ELECTRICAL CONNECTOR AND ELEVATOR CONTROL LEVER. THE INSERTION TUBE HAD WRINKLES THAT WERE ASSUMABLY DUE TO HUMIDITY INVASION. THE LG-LENS GLUE ON THE OUTER SURFACE COVER PEELED OFF BY DETERIORATION. THE STRANDS WERE BROKEN AT THE BENT AREA BY FATIGUE FRACTURE RESULTED FROM STRESS BY RAISING THE FORCEPS ELEVATOR. THE K-WIRE WAS BROKEN WHERE THE WIRE WAS BENT NEARLY 90 DEGREES IN ORDER TO MOUNT THE FORCEPS ELEVATOR. BENDING PROCESS MAY MAKE STRANDS BREAKABLE BY WORK-HARDENING. THE BROKEN AREA WAS PRONE TO RECEIVE THE REPEATED SHEAR STRESS BY RAISING THE FORCEPS ELEVATOR. FATIGUE FRACTURE IS PRONE TO OCCUR BY REPEATEDLY APPLYING THE SHEAR STRESS TO A BREAKABLE AREA. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS, THE DUODENOVIDEOSCOPE HAD A REDUCED ANGULATION AND A CUT OFF KNOB WIRE. THE ISSUE WAS FOUND DURING PREPARATION FOR USE PRIOR TO AN UNSPECIFIED DIAGNOSTIC PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, A RAISED KNOB WIRE AND DISCOLORED LIGHT GUIDE LENS WERE FOUND. THERE WERE NO REPORTS OF PATIENT HARM. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1769529 EVIS LUCERA DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT AIZU OLYMPUS CO., LTD. JF-260V

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown