BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA ELITE COLONOVIDEOSCOPE

    MDR report key: 14570367 · Received June 1, 2022

    Report

    Report Number
    1037007-2022-00007
    Event Type
    Malfunction
    Date Received
    June 1, 2022
    Date of Event
    May 5, 2022
    Report Date
    November 14, 2022
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE WAS RECEIVED AND EVALUATED. DEVICE INSPECTION AND EVALUATION, SERVICE REPAIR NOTED FOREIGN DEBRIS WAS FOUND PROTRUDING FROM THE AIR/WATER NOZZLE. SERVICE NOTED THE BLOCKAGE APPEARS TO BE A FIBROUS MATERIAL. TECHNICAL EVALUATION HAS CONFIRMED THE CUSTOMER SPECIFIED FAULT ¿CHANNEL BLOCKED¿. FURTHERMORE, THE FOLLOWING FINDINGS DURING DEVICE INSPECTION WERE NOTED BELOW: LIGHT COVER GLASSES CHIPPED. LIGHT COVER GLASSES WORN. OPTICAL COVER GLASS CHIPPED. OPTICAL COVER GLASS ADHESIVE WORN. DISTAL END ADHESIVE WORN. CONTROL BODY - ASPIRATION HOUSING FAIL COLORED RING WORN. SWITCH CONDITION HOLE IN BUTTON. UP/DOWN/RIGHT ANGLE NOT TO SPECIFICATION. UP/DOWN / LEFT/RIGHT ANGLE PAY EVIDENT. AIR CHANNEL - VOLUME- BLOCKAGE- FAIL WATER FLOW NOT TO SPECIFICATIONS WATER REMOVAL NOT TO SPECIFICATION. WATER CHANNEL - VOLUME -BLOCKAGE EVIDENT. SAFETY TEST FAIL- NOT TO SPECIFICATION. INVESTIGATION IS ONGOING. THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY FOLLOWING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO INFORM THE UPDATES/CORRECTION ON SECTIONS D3 AND G1 FROM THE INITIAL MDR REPORT. THE MANUFACTURER (SECTION D3), CONTACT OFFICE (G1) , AND MANUFACTURING SITE (G1) WERE UPDATED. PLEASE REFER TO SECTION D3 AND G1 FOR UPDATED INFORMATION. THE REGISTRATION NUMBER SHOULD BE 9610595 AND NOT 1037007.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE INVESTIGATION, POSSIBLE CAUSES MAY INCLUDE THE FOLLOWING: LINT AND/OR FIBERS FROM CLOTH USED TO WIPE THE DEVICE DURING REPROCESSING ENTERED THE AIR/WATER (A/W) CHANNEL. A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED. THIS ISSUE IS COVERED IN THE INSTRUCTIONS FOR USE: ·INSPECTION OF THE ENDOSCOPE : INSPECT THE EXTERNAL SURFACE OF THE ENTIRE INSERTION SECTION, INCLUDING THE BENDING SECTION AND THE DISTAL END FOR DENTS, BULGES, SWELLING, SCRATCHES, PEELING OF COATING, HOLES, SAGGING, TRANSFORMATION, BENDS, ADHESION OF FOREIGN BODIES, MISSING PARTS, PROTRUDING OBJECTS, OR OTHER IRREGULARITIES. "·INSPECTION OF THE ENDOSCOPIC SYSTEM. - INSPECTION OF THE AIR-FEEDING FUNCTION. - INSPECTION OF THE OBJECTIVE LENS CLEANING FUNCTION". THE USER CAN REDUCE AND PREVENT OCCURRENCE OF THE SUGGESTED EVENT BY HANDLING THE DEVICE IN ACCORDANCE WITH THE FOLLOWING IFU. ·CLEANING, DISINFECTION, AND STERILIZATION PROCEDURES - PRECLEANING - WIPE DOWN THE INSERTION SECTION - WIPE THE ENTIRE INSERTION SECTION WITH A CLEAN, LINT-FREE CLOTH SOAKED IN DETERGENT SOLUTION. WIPE FROM THE BOOT AT THE CONTROL SECTION TOWARD THE DISTAL END. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE.

    Description of Event or Problem · 0

    CUSTOMER REPORTED WITH AN ISSUE OF BLOCKAGE IN CHANNEL. THE ISSUE FOUND DURING REPROCESSING. THERE WAS NO PATIENT HARM REPORTED, NO USER INJURY REPORTED DUE TO THE EVENT. DEVICE EVALUATION FOUND A FOREIGN BLOCKAGE WAS IDENTIFIED PROTRUDING FROM THE OUTLET PIPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2812954 EVIS LUCERA ELITE COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF AIZU OLYMPUS CO., LTD. CF-HQ290L

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown