BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 15653946 · Received October 21, 2022

    Report

    Report Number
    9610595-2022-03198
    Event Type
    Malfunction
    Date Received
    October 21, 2022
    Date of Event
    September 12, 2022
    Report Date
    January 31, 2023
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE IS EXPECTED TO BE RETURNED TO OLYMPUS FOR EVALUATION AND FURTHER TESTING. THIS EVENT IS UNDER INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE RESULTS OF THE DEVICE EVALUATION, OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE CLEANING, DISINFECTION, AND STERILIZATION AND MICROBIAL TESTING RESULTS. AFTER THE DEVICE WAS RETURNED TO OLYMPUS, IT WAS SENT OUT FOR ADDITIONAL TESTING. THE MICROBIOLOGICAL ANALYSIS REPORT INDICATED THE CHANNELS OF THE SCOPE WERE CULTURED AND THE RESULTS OBTAINED COMPLY WITH THE TARGET LEVEL FOR AN ENDOSCOPE SUBJECTED TO HIGH LEVEL DISINFECTION AND RINSED WITH STERILE WATER. THE CLEANING, DISINFECTION, AND STERILIZATION (CDS) WAS PERFORMED BY THE CUSTOMER. PRE-CLEANING INVOLVED ASPIRATION OF WATER THROUGH THE INSTRUMENT AND SUCTION CHANNEL. THE AIR/WATER CHANNEL WAS FLUSHED. NO DETERGENT WAS USED FOR PRE-CLEANING. MANUAL CLEANING INVOLVED BRUSHING THE INSTRUMENT/SUCTION CHANNELS, SUCTION CYLINDER, INSTRUMENT CHANNEL PORT, DISTAL END, AND HANDLE. DURING MANUAL CLEANING, AN ASEPT INMED REF 201789 BRUSH AND DISSAL REF FR123 BRUSH WAS USED WITH ANIOS XL3 DETERGENT. MANUAL DISINFECTION WAS NOT DONE. THE AUTOMATIC ENDOSCOPE REPROCESSOR (AER) USED WAS SOLUSCOPE S3 & S4. SOLUSCOPE C+ WAS USED AS THE DETERGENT AND SOLUSCOPE PA WAS USED AS THE DISINFECTANT. THE SCOPE WAS STORED HORIZONTALLY IN A CABINET WITH NO DRYING FUNCTION. THE SCOPE WAS NOT STERILIZED. THE SOLUSCOPE S3 & S4 AERS WERE EACH TESTED TWICE AND BOTH AERS HAD LESS THAN 1 CFU CULTURED DURING EACH TEST. THIS EVENT IS UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON RECEIVING ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE DEVICE EVALUATION AND THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE FOLLOWING DEVIATION WAS CONFIRMED BY REVIEW OF REPROCESSING STEPS PROVIDED BY THE USER: - FLUSHING WAS NOT PERFORMED FOR AUXILIARY WATER CHANNEL AT PRECLEANING. THE DEVICE WAS EVALUATED WHERE NO ABNORMALITIES WERE FOUND THAT COULD HAVE LED TO THE POSITIVE CULTURE. DEFECTS WERE NOTED WHERE: - CHARGED COUPLED DEVICE (CCD) COVER LENS --- SCRATCHED - CCD COVER LENS --- CHIPPED - DISTAL END CAP COVER -- - SCRATCH - BENDING SECTION (A)-RUBBER GLUE --- SEPARATED - A-RUBBER GLUE --- DISCOLORATION - STOPPER --- WEAR AND TEAR - SWITCH 2 --- DAMAGED 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. GROWTH OF MICROORGANISMS WERE FOUND THROUGH CULTURE TESTING BY THE USER AFTER REPROCESSING. HOWEVER, WHEN OLYMPUS CULTURE TESTED AFTER REPROCESSING IN ACCORDANCE WITH 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." "FLUSH THE AUXILIARY WATER CHANNEL" IS STATED IN IFU UNDER "PRECLEANING THE ENDOSCOPE AND ACCESSORIES". OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE GASTROINTESTINAL VIDEOSCOPE TESTED POSITIVE FOR MICROBIAL 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. ADDITIONAL DETAILS HAVE BEEN REQUESTED REGARDING THE REPORTED ISSUE, SUCH AS, THE RESULTS OF THE MICROBIOLOGICAL TESTING, AND THE CUSTOMER'S CLEANING, DISINFECTION, AND STERILIZATION PROCESSES. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2240989 GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS AIZU OLYMPUS CO., LTD. GIF-1100

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown