BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA LLL COLONOVIDEOSCOPE

    MDR report key: 13007189 · Received December 15, 2021

    Report

    Report Number
    8010047-2021-16143
    Event Type
    Malfunction
    Date Received
    December 15, 2021
    Date of Event
    November 17, 2021
    Report Date
    April 1, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDF
    UDI-DI
    04953170305191
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS SUBMITTED TO PROVIDE THE DEVICE EVALUATION, THE LEGAL MANUFACTURER¿S INVESTIGATION, THE DEVICE HISTORY RECORD (DHR) REVIEW AND APPLICABLE CORRECTIONS. UPON COMPLETION OF THE INDEPENDENT LABORATORY CULTURING, THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION. THE GLUE ON THE BENDING SECTION COVER WAS PEELING OFF, THERE WAS KNOB PLAY AND THERE WAS REDUCED ANGULATION. THE REVIEW OF THE DHR DID NOT FIND ANY ABNORMALITIES OR ANOMALIES IDENTIFIED DURING PRODUCTION. THE DEVICE MET ALL SPECIFICATIONS UPON RELEASE. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED. ENTEROBACTER CLOACAE, AND ACINETOBACTER BAUMANNII WERE DETECTED FROM THE CHANNEL IN CULTURE TESTING BY THE USER AFTER REPROCESSING. HOWEVER, THE SAME KIND OF MICROORGANISM WAS NOT DETECTED FROM THE CHANNEL WHEN THE INDEPENDENT CULTURE TESTED OCCURRED AFTER REPROCESSING WAS PERFORMED IN ACCORDANCE WITH INSTRUCTIONS FOR USE (IFU). THE INSTRUCTIONS FOR USE (IFU) CAUTIONS THE USERS OF INCORRECTLY REPROCESSING AND PROPER HANDLING OF THE DEVICE: IFU (REPROCESSING MANUAL) STATES AS FOLLOWS: ¿REPROCESSING MANUAL:1.4 PRECAUTIONS: WARNING: AN INSUFFICIENTLY REPROCESSED ENDOSCOPE AND/OR ACCESSORY MAY POSE AN INFECTION CONTROL RISK TO THE PATIENTS AND/OR OPERATORS WHO TOUCH THEM.¿ OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE OLYMPUS SCOPE WAS SENT TO AN INDEPENDENT LABORATORY FOR CULTURE TESTING. ALL CHANNELS WERE SAMPLED AND THE RESULTS WERE DETERMINED TO BE CONFORMING. THE OBTAINED RESULTS ARE IN CONFORMANCE WITH THE REQUIREMENTS. THE USER FACILITY PROVIDED ADDITIONAL INFORMATION REGARDING THE CLEANING, THE DISINFECTION AND THE STERILIZATION PROCESSES PERFORMED ONSITE FOR THE ENDOSCOPES. THE CUSTOMER USES DETERGENT ANIOSYME X3 DURING MANUAL CLEANING. THE OPERATING/SUCTION CHANNEL, THE SUCTION PISTON, THE OPENING OF THE OPERATING CHANNEL AND THE DISTAL END/AREAS AROUND THE ELEVATOR ARE CLEANED MANUALLY WITH ASEPT INMED (201780) BRUSHES. FOR AUTOMATIC ENDOSCOPE REPROCESSING, THE CUSTOMER USES AUTOMATIC ENDOSCOPE REPROCESSOR (AER) SOLUSCOPE 4, ALONG WITH DETERGENT SOLUSCOPE CLN AND DISINFECTANT SOLUSCOPE PAA. THE ENDOSCOPES ARE VERTICALLY HUNG AND STORED IN A SOLUSCOPE DRYING CABINET (AS300). OLYMPUS IS THE MAINTENANCE COMPANY THE CUSTOMER USES. THE DEVICE EVALUATION IS IN PROCESS. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS, THE EVIS EXERA III COLONOVIDEOSCOPE TESTED POSITIVE FOR OVER 250 COLONY FORMING UNITS (CFUS) OF ENTEROBACTER CLOACAE COMPLEX AND ACINETOBACTER BAUMANNII WHEN THE AUXILIARY CHANNEL, THE BIOPSY CHANNEL AND THE SUCTION CHANNEL WERE TESTED. THE ISSUE WAS FOUND DURING A ROUTINE CULTURE OF THE SCOPE. THE USER DID NOT REPORT ANY CONTAMINATION OR ANY OTHER SERIOUS DETERIORATION IN STATE OF HEALTH OF ANY PERSON, TO WHICH THE SCOPE COULD HAVE BEEN A CONTRIBUTORY CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1907252 EVIS EXERA LLL COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF OLYMPUS MEDICAL SYSTEMS CORP. PCF-H190L 04953170305191

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown