BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III COLONOVIDEOSCOPE

    MDR report key: 12310119 · Received August 11, 2021

    Report

    Report Number
    8010047-2021-10107
    Event Type
    Malfunction
    Date Received
    August 11, 2021
    Date of Event
    July 15, 2021
    Report Date
    September 15, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDF
    UDI-DI
    04953170305115
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER¿S INVESTIGATION AND THE RESULTS OF THE DEVICE HISTORY RECORDS (DHR) REVIEW. THE DHR FOR THIS DEVICE WERE REVIEWED AND ALL RECORDS INDICATED THE PRODUCT WAS MANUFACTURED ACCORDING TO ALL APPLICABLE PROCEDURES AND MET FINAL PRODUCT RELEASE CRITERIA. NO ABNORMALITIES WERE FOUND. A DEFINITIVE ROOT CAUSE WAS NOT IDENTIFIED. BASED ON THE AVAILABLE INFORMATION, THE LEGAL MANUFACTURER DETERMINED THE PROBABLE CAUSE OF THE FAILURE IS LIKELY DUE TO THE USER NOT ADEQUATELY BRUSH OR PROPERLY APPLY WATER FLOW DURING PRE-CLEANING OR MANUAL CLEANING. THE INSTRUCTIONS FOR USE PROVIDED TO THE CUSTOMER INCLUDE THE FOLLOWING DETAILS: IF THE SUCTION VALVE CLOGS AND THE SUCTION CANNOT BE USED WHEN SOLID MATTER, SUCH AS THE CLIP OR THICK FLUID, ARE ASPIRATED, WITHDRAW THE ENDOSCOPE AND DISCONNECT THE SUCTION TUBE FROM THE SUCTION CONNECTOR ON THE ENDOSCOPE CONNECTOR. ATTACH A SYRINGE CONTAINING STERILE WATER TO THE SUCTION CONNECTOR. STRAIGHTEN THE INSERTION TUBE AS MUCH AS POSSIBLE AND FORCEFULLY FLUSH THE CONNECTOR WITH THE WATER WHILE THE SUCTION VALVE OF THE ENDOSCOPE IS SLIGHTLY DEPRESSED. REPEAT THE FLUSH UNTIL THE THICK FLUID OR SOLID MATTER ARE DISCHARGED FROM THE DISTAL END OF THE SUCTION CHANNEL. AFTER DISCHARGING, CONFIRM THAT THERE IS NO IRREGULARITY IN THE SUCTION FUNCTION ACCORDING TO ¿INSPECTION OF THE SUCTION FUNCTION¿ ON PAGE 50, BEFORE USING THE ENDOSCOPE AGAIN. IF THE THICK FLUID OR SOLID MATTER CANNOT BE DISCHARGED, STOP USING THE SUCTION FUNCTION AND CONTACT OLYMPUS. 3.8 INSPECTION OF THE ENDOSCOPIC SYSTEM: INSPECTION OF THE INSTRUMENT CHANNEL: 1 INSERT THE ENDO THERAPY ACCESSORY THROUGH THE BIOPSY VALVE. CONFIRM THAT THE ENDO THERAPY ACCESSORY EXTENDS SMOOTHLY FROM THE DISTAL END. ALSO MAKE SURE THAT NO FOREIGN OBJECTS COME OUT OF THE DISTAL END. 2 CONFIRM THAT THE ENDO THERAPY ACCESSORY CAN BE WITHDRAWN SMOOTHLY FROM THE BIOPSY VALVE. REPROCESSING MANUAL: PRECLEANING THE ENDOSCOPE AND ACCESSORIES¿ SAYS ABOUT PRECLEANING TO BE TAKEN IMMEDIATELY AFTER PROCEDURE AS BELOW: IF THE ENDOSCOPE AND ACCESSORIES USED IN THE PATIENT PROCEDURE ARE NOT IMMEDIATELY CLEANED AFTER EACH PATIENT PROCEDURE, RESIDUAL ORGANIC DEBRIS WILL BEGIN TO DRY AND SOLIDIFY, HINDERING EFFECTIVE REMOVAL AND REPROCESSING EFFICACY. PRECLEAN THE ENDOSCOPE AND THE ACCESSORIES AT THE BEDSIDE IN THE PATIENT PROCEDURE ROOM IMMEDIATELY AFTER EACH PATIENT PROCEDURE.

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION AND THE INVESTIGATION IS IN PROCESS. THE CUSTOMER REPORTED THE BLOCKAGE IN THE CHANNEL WAS RESOLVED BY SOAKING AND FLUSHING IT WITH DETERGENT. EVENTUALLY, A VAST AMOUNT OF ODDLY SHAPED SEEDS EXITED FROM THE CHANNEL. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH DEVICE EVALUATION RESULTS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO OLYMPUS, THERE WAS A BLOCKAGE IN THE SUCTION CHANNEL OF THE DEVICE AND THE CHANNEL COULD NOT BE BRUSHED IN REPROCESSING. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1207808 EVIS EXERA III COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF OLYMPUS MEDICAL SYSTEMS CORP. CF-HQ190L 04953170305115

    Patients

    Seq Age Sex Outcome Treatment
    1