BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 16299227 · Received February 3, 2023

    Report

    Report Number
    9610595-2023-01784
    Event Type
    Malfunction
    Date Received
    February 3, 2023
    Date of Event
    December 18, 2022
    Report Date
    April 27, 2023
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDS
    UDI-DI
    04953170305276
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE OLYMPUS SCOPE WAS SENT TO AN INDEPENDENT LABORATORY FOR CULTURE TESTING. NO MICRO-ORGANISMS WERE DETECTED. THE OBTAINED RESULTS ARE IN CONFORMANCE WITH THE REQUIREMENTS. THE DEVICE WAS EVALUATED BY OLYMPUS. THE AIR/WATER AND SUCTION CYLINDERS WERE DISCOLORED, THE SWITCH BOX WAS DEFORMED, THE GRIP WAS SCRATCHED, THE SCOPE COVER WAS SCRATCHED AND DISCOLORED, THE PLUG UNIT WAS DEFORMED, THE OBJECTIVE LENS WAS SCRATCHED AND THE ADHESIVE AROUND THE LIGHT LENS WAS PEELED. THE CONNECTING TUBE HAD A DENT AND SNAG AND WAS BUCKLED. DUE TO THE WORN ANGLE WIRE, THE BENDING ANGLE IN THE UP/DOWN AND RIGHT DIRECTIONS, THE VALUES DID NOT MEET SPECIFICATION. THE CHANNEL TUBE WAS SCRATCHED, THE UNIVERSAL CORD WAS BUCKLED AND HAD PEELING COATING. THE CUSTOMER PROVIDED THE CLEANING, DISINFECTION, AND STERILIZATION (CDS) PRACTICES PERFORMED ONSITE. DURING PRE-CLEANING, THE CUSTOMER ASIPERATES WATER THROUGH THE INSTRUMENT/SUCTION CHANNEL AND FLUSHES OUT THE AIR/WATER AND AUXILLIARY WATER CHANNELS. THE CUSTOMER USES A DETERGENT FOR PRE-CLEANING, HOWEVER, THE NAME OF THE DETERGENT WAS NOT PROVIDED. THE CUSTOMER USES DETERGENT ANIOSYME 3X DURING MANUAL CLEANING. DURING MANUAL CLEANING, THE CUSTOMER BRUSHES THE OPERATING CHANNEL, SUCTION CYLINDER,AND THE INSTRUMENT CHANNEL PORT USING OLYMPUS BW-20T BRUSHES. THE CUSTOMER USES MICRO TECH DISPOSABLE CLEANING BRUSHES, ENDO-FLEX CLEANING BRUSHES AND SU ENDO-FLEX CLEANING BRUSHES. FOR AUTOMATIC ENDOSCOPE REPROCESSING, THE USER FACILITY USES AER SOLUSCOPE 4, ALONG WITH DETERGENT SOLUSCOPE CLN AND DISINFECTANT SOLUSCOPE PAA. THE ENDOSCOPES ARE STORED IN A SOLUSCOPE CABINET (SOLUSCOPE_ANIOS DSC8000) AND OLYMPUS IS THE COMPANY IS THE MAINTENANCE COMPANY THE USER FACILITY USES. 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.

    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 INSTRUCTIONS FOR USE (IFU) BEFORE REPAIR, THE RESULTS CONFORMED TO THE REGULATION'S RECOMMENDATION. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS, LIQUID FROM THE BIOPSY CHANNEL FROM THE EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE TESTED POSITIVE FOR 19 COLONY FORMING UNITS (CFUS) OF PSEUDOMONAS AERUGINOSA. THE SAMPLING OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1327505 EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS AIZU OLYMPUS CO., LTD. GIF-HQ190 04953170305276

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown