BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III COLONOVIDEOSCOPE

    MDR report key: 14842775 · Received June 28, 2022

    Report

    Report Number
    8010047-2022-10932
    Event Type
    Malfunction
    Date Received
    June 28, 2022
    Date of Event
    March 23, 2022
    Report Date
    December 15, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDF
    UDI-DI
    04953170305177
    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

    THE SUSPECT DEVICE HAS BEEN RETURNED TO OLYMPUS FOR EVALUATION AND THE INVESTIGATION IS IN PROCESS. THE PHYSICAL DEVICE EVALUATION HAS NOT YET BEEN COMPLETED. THE CUSTOMER PROVIDED THEIR CLEANING, DISINFECTION, AND STERILIZATION PROCESS. THE SCOPES ARE PRE-CLEANED BY ASPIRATING WATER THROUGH THE INSTRUMENT/SUCTION CHANNEL. THE AIR/WATER CHANNEL IS ALSO FLUSHED. THE DETERGENT USED FOR PRE-CLEANING IS ANIOS CLEAN EXCEL 9. THE SCOPES ARE MANUALLY CLEANED USING AN ASEPT (RE: 201 664) BRUSH. THE AUTOMATED ENDOSCOPIC REPROCESSOR (AER) USED IS A SOLUSCOPE AER, UTILIZING SOLUSCOPE PAA DETERGENT AND SOLUSCOPE CLN DISINFECTANT. SCOPES ARE STORED VERTICALLY IN A NON-OLYMPUS DRYING CABINET (VAN VLIET EDC). OLYMPUS IS THE MAINTENANCE COMPANY FOR THE SCOPE. THE SCOPES ARE NOT STERILIZED. THE AER WAS ALSO TESTED FOR MICROBIOLOGICAL CONTAMINATION; HOWEVER, THE TEST RESULTS WERE NOT PROVIDED. AFTER THE DEVICE WAS RETURNED TO OLYMPUS, IT WAS SENT TO AN INDEPENDENT LABORATORY FOR ADDITIONAL TESTING. THE HYGIENE MICROBIOLOGICAL INVESTIGATION REPORT INDICATED THE CHANNELS OF THE SCOPE WERE CULTURED. ONE (1) COLONY FORMING UNIT (CFU) OF PSEUDOMONAS AERUGINOSA BACTERIA WERE IDENTIFIED. AS A RESULT OF THE TEST RESULTS, THE SCOPE WILL UNDERGO ADDITIONAL CULTURING, WHICH IS CURRENTLY PENDING. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH DEVICE EVALUATION RESULTS.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON CLARIFICATION TO RESULTS OF THIRD PARTY TESTING (PLEASE SEE B6), THE DEVICE EVALUATION, AND THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE DEVICE WAS EVALUATED WHERE NO ABNORMALITIES WERE FOUND THAT COULD HAVE LED TO THE POSITIVE CULTURE. MULTIPLE DEFECTS WERE NOTED WHERE: - DISTAL END CAP COVER --- INSULATION < THRESHOLD - DISTAL END CAP COVER --- SCRATCH - BENDING SECTION RUBBER GLUE --- WORN OUT - CONNECTING TUBE --- SLIGHTLY PEEL OFF - SCOPE BODY --- DAMAGED - SCOPE COVER --- BROKEN - AIR/WATER CYLINDER --- SCRATCHED, BLUE PAINT AROUND AIR/WATER CYLINDER FADED OR MISSING - SUCTION CYLINDER --- SCRATCHED, RED PAINT AROUND SUCTION CYLINDER FADED/MISSING - SWITCH 1 --- WEAR AND TEAR - UNIVERSAL CORD --- WRINKLE - SCOPE CONNECTOR COVER --- DAMAGED - BENDING TUBE --- MOVEMENT (ANGULATION 170/170/150/140) - AIR WATER CHANNEL --- WEAR AND TEAR (REPLACED AS PREVENTIVE MAINTENANCE, NO CHANNELS CLOGGED) - BIOPSY CHANNEL --- WEAR AND TEAR (REPLACED AS PREVENTIVE MAINTENANCE, NO CHANNELS CLOGGED) HOWEVER, THESE DEFECTS ALONE ARE NOT CONSIDERED SEVERE ENOUGH TO CAUSE A POTENTIAL ADVERSE EVENT. 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, A ROOT CAUSE COULD NOT BE DETERMINED. THE FOLLOWING IS INCLUDED IN THE DEVICE IFU: "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 FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS THAT THE SUBJECT DEVICE TESTED POSITIVE FOR AN UNEXPECTED CONTAMINATION. THE ISSUE WAS FOUND DURING A ROUTINE CULTURE OF THE SCOPE. THE USER DID NOT REPORT ANY CONTAMINATION OR ANY OTHER SERIOUS DETERIORATION IN THE 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
    910937 EVIS EXERA III COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF OLYMPUS MEDICAL SYSTEMS CORP. CF-H190I 04953170305177

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown