BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA ELITE COLONOVIDEOSCOPE

    MDR report key: 15960442 · Received December 12, 2022

    Report

    Report Number
    9610595-2022-05258
    Event Type
    Malfunction
    Date Received
    December 12, 2022
    Report Date
    February 20, 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 FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 8 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED. THE SUGGESTED PHENOMENON WAS PRESUMED TO HAVE BEEN DUE TO FOREIGN MATERIAL WHICH WAS BIGGER THAN THE INNER DIAMETER OF THE AIR/WATER NOZZLE ENTERING INSIDE THE AIR/WATER CHANNEL, WHICH THEN RESULTED IN CLOGGING. THE CAUSE OF ENTERING OF THE FOREIGN MATERIAL WAS UNABLE TO BE SPECIFIED SINCE DETAILED INFORMATION OF HANDLING WAS UNAVAILABLE. IT WAS CONFIRMED THAT THE AIR/WATER NOZZLE WAS NOT DEFORMED. IT WAS ALSO CONFIRMED THAT THE FOREIGN MATERIAL REMAINED IN THE NOZZLE. BASED ON THE INVESTIGATION OF THE USER¿S REPROCESSING CONDITION, IT WAS CONFIRMED THAT REPROCESSING WAS PERFORMED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    FULL NAME OF THE FACILITY IS MEDICAL CORPORATION (B)(6) THIS DEVICE IS NOT SOLD IN THE U.S., BUT A SIMILAR DEVICE IS. THE DEVICE IS RETURNED, AND AN EVALUATION COMPLETED FOR IT. UPON INSPECTION AND TESTING, IT WAS OBSERVED THAT THERE WAS FOREIGN MATERIAL CLOGGING THE NOZZLE. THIS IS ATTRIBUTED TO THE FAILURE TO CLEAN ADEQUATELY. DUE TO CLOGGING OF NOZZLE, AIR SUPPLY VOLUME DOES NOT MEET THE STANDARD VALUE. DUE TO CLOGGING OF NOZZLE, WATER REMOVAL ABILITY AND WATER SUPPLY VOLUME DO NOT MEET THE STANDARD VALUE. OTHER OBSERVATIONS FOR THE DEVICE: ADHESIVE ON DISTAL END RUBBER COATING (A-RUBBER) HAS A CHIP AND WHITE-CLOUDED AREA; DUE TO WEAR OF ANGLE WIRE, THE PLAY OF UP/DOWN KNOB AND BENDING ANGLE IN UP DIRECTION IS OUT OF THE STANDARD VALUE; DISTAL END COVER (C-COVER) HAS A DENT; ADHESIVE AROUND LIGHT GUIDE (LG) LENS IS PEELED; LG LENS HAS CRACK; ADHESIVE AROUND OBJECTIVE LENS IS PEELED; OBJECTIVE LENS HAS A CRACK; GRIP IS SHAVED; SWITCH (SW) SW4, SW3, AND SW1 HAVE WEAR; MOUTHPIECE IS LOOSE; AN ABNORMAL SOUND IS MADE DUE TO DAMAGE ON UP/DOWN KNOB; CONNECTING TUBE HAS A CUT; AND INSERTION TUBE NON-BENDING SECTION IG PROTECTOR, SUCTION CYLINDER, SW1, AND PROTECTOR OF UNIVERSAL CORD HAVE A SCRATCH. USER COMPLAINT OF POOR AIR/WATER SUPPLY WAS CONFIRMED. EVALUATION IS ONGOING. SUPPLEMENTAL REPORT(S) WILL BE SUBMITTED WHEN ANY RELEVANT NEW INFORMATION IS AVAILABLE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION ON REPROCESSING HAS BEEN RECEIVED FOR THIS EVENT FROM THE CUSTOMER. THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THIS INFORMATION. PLEASE SEE THE UPDATES IN SECTIONS: THE DEVICE WAS CLEANED, DISINFECTED, AND STERILIZED BEFORE REQUESTING REPAIR. PRESENCE OF FOREIGN MATERIAL ADHERING TO THE DEVICE WAS NOT KNOWN. PRE-CLEANING INFORMATION: THERE WAS NO DELAY TO THE START OF PRE-CLEANING WHICH WAS DONE PROPERLY. WATER AND AIR WAS SUPPLIED TO THE AIR/WATER NOZZLE. INFORMATION ON MANUAL CLEANING: THE ACCESSORIES USED FOR REPROCESSING WERE NORMAL AND WITHOUT ISSUES. THE AIR/WATER NOZZLE WAS WIPED OR BRUSHED WITH GAUZE, BRUSH, OR SPONGE. LIQUID WAS SENT TO THE AIR/WATER NOZZLE.

    Description of Event or Problem · 0

    CUSTOMER RETURNED THE DEVICE FOR EVALUATION AND REPAIR OF POOR AIR/WATER SUPPLY. THERE IS NO REPORTED HARM TO ANY PATIENT. UPON EVALUATION OF THE RETURNED DEVICE, IT WAS OBSERVED THAT THERE WAS FOREIGN MATERIAL CLOGGING THE NOZZLE. THIS IS ATTRIBUTED TO THE FAILURE TO CLEAN ADEQUATELY. DUE TO CLOGGING OF NOZZLE, AIR SUPPLY VOLUME DOES NOT MEET THE STANDARD VALUE. DUE TO CLOGGING OF NOZZLE, WATER REMOVAL ABILITY AND WATER SUPPLY VOLUME DO NOT MEET THE STANDARD VALUE. THIS MEDWATCH IS BEING SUBMITTED FOR THE REPORTABLE ISSUE OF FOREIGN MATERIAL FOUND IN THE NOZZLE DURING DEVICE EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425107 EVIS LUCERA ELITE COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF AIZU OLYMPUS CO., LTD. PCF-H290I

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown