BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II COLONOVIDEOSCOPE

    MDR report key: 14955363 · Received July 8, 2022

    Report

    Report Number
    8010047-2022-11566
    Event Type
    Malfunction
    Date Received
    July 8, 2022
    Date of Event
    June 9, 2022
    Report Date
    October 21, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDF
    UDI-DI
    04953170202537
    PMA / PMN Number
    K001241
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURE'S REVIEW OF THE CUSTOMER PROVIDED CLEANING DISINFECTION AND STERILIZATION (CDS) PRACTICES, RESULTS OF THIRD PARTY TESTING, THE DEVICE EVALUATION, AND THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE FOLLOWING DEVIATION WAS CONFIRMED BY REVIEW OF REPROCESSING STEPS PROVIDED FROM THE USER: FLUSHING WAS NOT PERFORMED FOR AUXILIARY WATER CHANNEL AT PRECLEANING. THE FOLLOWING WAS RESULT OF THE CULTURE TEST PERFORMED AT THE THIRD-PARTY LABS, PROVIDED FROM OLYMPUS: SAMPLING FROM: ALL CHANNELS. CFU: 1CFU. BACTERIAL IDENTIFICATION: BACTERIA GRAM POSITIVE. THE DEVICE WAS EVALUATED WHERE MULTIPLE DEFECTS WERE NOTED INCLUDING: THIRD PARTY REPAIRED LIGHT GUIDE LENSES . THIRD PARTY REPAIRED LENSES CEMENTING . THIRD PARTY REPAIRED DISTAL END CAP . THIRD PARTY REPAIRED BENDING SECTION RUBBER. THIRD PARTY REPAIRED INSERTION TUBE AND PROTECTOR . THIRD PARTY REPAIRED BUTTONS. THIRD PARTY REPAIRED PROTECTORS GRIP & COLOR RING. SEAT HOLDER UNIT CONNECTOR CORRODED . BIOPSY CHANNEL LESS THAN SPECIFIED VALUE. DISTAL END NOZZLE DAMAGE. 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, IT IS LIKELY THAT THE EVENT OCCURRED DUE TO DEVIATION FROM THE INSTRUCTION IN THE DEVICE INSTRUCTIONS FOR USE (IFU). GROWTH OF MICROORGANISMS WERE FOUND THROUGH CULTURE TESTING BY THE USER AFTER REPROCESSING. HOWEVER, WHEN OLYMPUS CULTURE TESTED AFTER REPROCESSING IN ACCORDANCE WITH IFU BEFORE REPAIR, THE RESULTS CONFORMED TO THE REGULATION'S RECOMMENDATION. 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." "THIS INSTRUMENT DOES NOT CONTAIN ANY USER-SERVICEABLE PARTS. DO NOT DISASSEMBLE, MODIFY OR ATTEMPT TO REPAIR IT; PATIENT OR OPERATOR INJURY AND/OR EQUIPMENT DAMAGE CAN RESULT. EQUIPMENT WHICH HAS BEEN DISASSEMBLED, REPAIRED, ALTERED, CHANGED OR MODIFIED BY PERSONS OTHER THAN OLYMPUS¿ OWN AUTHORIZED SERVICE PERSONNEL IS EXCLUDED FROM OLYMPUS¿ LIMITED WARRANTY AND IS NOT WARRANTED BY OLYMPUS IN ANY MANNER." OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. THE INVESTIGATION IS ONGOING; THEREFORE, THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED AT THIS TIME. HOWEVER, IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

    Description of Event or Problem · 0

    THE USER PROVIDED ADDITIONAL INFORMATION BASED ON THE DEVICE CLEANING DISINFECTION AND SANITIZATION (CDS) PRACTICES WHERE THE DETERGENT USED FOR PRE-CLEANING IS DDN 9. THE DEVICE IS MANUALLY PROCESSED DDN 9 DETERGENT, THE CLEANING BRUSH WAS NOT LISTED. THE DEVICE IS NOT MANUALLY DISINFECTED. THE DEVICE IS PROCESSED IN A WASSENBERG AUTOMATED ENDOSCOPE REPROCESSOR (AER) WITH ENDOHIGH DETERGENT AND ENDOHIGH PAA DISINFECTANT. THE DEVICE IS STORED IN A WASSENBERG DRY 300 DRYING CABINET. OLYMPUS IS NOT THE MAINTENANCE PROVIDER OF THE SUBJECT DEVICE AND THE MAINTENANCE PROVIDED WAS NOT PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS, A ROUTINE MICROBIOLOGICAL CULTURE WAS PERFORMED ON ALL CHANNELS OF THE EVIS EXERA II COLONOVIDEOSCOPE. THE SCOPE TESTED POSITIVE FOR GREATER THAN ONE HUNDRED (100) COLONY FORMING UNITS (CFUS) OF ALCALIGENES XYLOSOXIDANS. THERE WAS NO REPORTED 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
    2851119 EVIS EXERA II COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF OLYMPUS MEDICAL SYSTEMS CORP. CF-Q165I 04953170202537

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown