BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 17353922 · Received July 19, 2023

    Report

    Report Number
    9610595-2023-10318
    Event Type
    Malfunction
    Date Received
    July 19, 2023
    Date of Event
    June 14, 2023
    Report Date
    August 7, 2023
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDS
    UDI-DI
    04953170420191
    PMA / PMN Number
    K222584
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE OLYMPUS FRANCE FRENCH OLYMPUS SUBSIDIARY FOR HYGIENE MICROBIOLOGICAL INVESTIGATION (HMI) PERFORMED A CULTURE TEST FOR THE DEVICE AFTER THE DEVICE WAS REPROCESSED. THE RESULTS REPORTED DEVICE CHANNEL (ALL CHANNELS) CONFORMS TO RESULTS OF <1 CFU/100 ML AND <1 CFU/ENDOSCOPE (MICROORGANISM REVIVABLE) . THE RESULTS OBTAINED COMPLY WITH THE TARGET LEVEL DEFINED IN INSTRUCTION DGOS/PF2/DGS/VSS1/2016/220 OF JULY 4, 2016. THE RESULTS ARE CONFORM TO FRENCH RECOMMENDATION. THE DEVICE WAS THEN RETURNED TO RRC (REGIONAL REPAIR CENTER) FRANCE OLYMPUS FOR DEVICE EVALUATION. THE DEVICE INSPECTION AND EVALUATION FINDINGS NOTED BELOW: LIGHT GUIDE COVER LENS WERE CHIPPED. DISTAL END C-COVER CHIPPED. INSULATION DISTAL END (D/E) FAILED A-RUBBER (BENDING COVER INSERTION PART ) WHITE CLOUDED. CONNECTING TUBE BUCKLES. UNIVERSAL CORD WRINKLE. ANGULATION TEST FAILED (OUT OF SPECIFICATIONS FOR UP/DOWN KNOB) THE CUSTOMER PROVIDED THE CLEANING, STERILIZATION, AND DISINFECTION (CDS) PROCESSES PERFORMED AT THE USER FACILITY. THE CUSTOMER DID CONFIRM THAT THERE WERE NO DEVIATIONS OR DEFICIENCIES CONCERNING THE REPROCESSING OF THE SCOPE. ADDITIONALLY, THE CUSTOMER CONFIRMED THAT THERE WERE NO SUSPECTED PATIENT INFECTIONS DUE TO THE FACILITY'S FINDINGS. THE DEVICE PASSED THE LEAK TEST. THE INSTRUMENT/SUCTION CHANNEL AND SUCTION CYLINDER INSTRUMENT CHANNEL PORT WERE BRUSHED. THERE WAS NO DEFECT ON AER/EWD. ALL CHANNELS WERE CONNECTED WITH TUBES WHEN THE ENDOSCOPE WAS SETTING UP TO INTO THE AER/EWD. THE CONCENTRATION AND EXPIRATION DATE OF THE DISINFECTANT WAS CONTROLLED. THE WATER QUALITY OF THE RINSE WATER WAS CONTROLLED. THE WATER FILTER WAS REPLACED PERIODICALLY IN ACCORDANCE WITH IFU. THE DEVICE WAS DRIED BY BLOWING IT WITH FILTERED COMPRESSED AIR. THE FLAT TRAY WAS USED FOR ENDOSCOPE STORAGE.  OLYMPUS IS THE MAINTENANCE COMPANY. THE CLEANING, DISINFECTION, AND STERILIZATION (CDS) WAS PERFORMED BY THE CUSTOMER. THERE WAS NO PATIENT INFECTION. INVESTIGATION IS ONGOING. THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY FOLLOWING INVESTIGATION.

    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. BASED ON THE RESULTS OF THE INVESTIGATION, A ROOT CAUSE COULD NOT BE DETERMINED. GROWTH OF MICROORGANISMS WERE FOUND THROUGH CULTURE TESTING BY THE USER AFTER REPROCESSING. HOWEVER, WHEN OLYMPUS CULTURE TESTED AFTER REPROCESSING IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (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." OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS, DURING REPROCESSING, THE GASTROINTESTINAL VIDEOSCOPE TESTED POSITIVE FOR 19 COLONY FORMING UNITS (CFUS) OF PSEUDOMONAS AERUGINOSA, KLEBSIELLA OXYTOCA, ENTEROBACTER CLOACAE COMPLEX, AND ENVIRONMENTAL SAPROPHYTIC BACTERIA. ALL CHANNELS WERE SAMPLED. 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
    894549 GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS AIZU OLYMPUS CO., LTD. GIF-1100 04953170420191

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown