BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA ¿ GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 12585071 · Received October 6, 2021

    Report

    Report Number
    8010047-2021-12809
    Event Type
    Malfunction
    Date Received
    October 6, 2021
    Report Date
    May 8, 2024
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDS
    UDI-DI
    04953170202308
    PMA / PMN Number
    K011151
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO CORRECT THE FOLLOWING: CORRECTION TO G2 TO ADD THE FOREIGN COUNTRY ITALY. CORRECTION TO H6 "INVESTIGATION FINDINGS" OF THE FIRST SUPPLEMENTAL REPORT. PLEASE SEE H6 FOR FURTHER DETAIL. 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 WITH NO GERMS DETECTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE USER FACILITY PROVIDED ADDITIONAL INFORMATION REGARDING THE METHODS USED TO CLEAN, DISINFECT AND STERILIZE THE ENDOSCOPES. AT THE FACILITY, DURING PRELIMINARY CLEANING, WATER IS SUCTIONED THROUGH THE SUCTION/OPERATING CHANNEL AND THE AIR/WATER CHANNEL IS WASHED USING THE DETERGENT ANIOSYME. DURING MANUAL CLEANING, THE DISINFECTANT USED IS ISAPOR AND DETERGENT USED IS ISACLEAN. BRUSHES (OLYMPUS MODEL BW412T AND BATRIK MODEL 30-23050-2T) ARE USED TO CLEAN THE SUCTION/OPERATING CHANNEL, THE SUCTION CYLINDER, THE OPERATIONAL CHANNEL, AND THE AREAS AROUND THE ELEVATOR. THE AUTOMATED ENDOSCOPE REPROCESSOR (AER) IS ISA MEDIVATOR. THE DISINFECTANT USED IS ISAPOR AND DETERGENT USED IS ISACLEAN. THE DEVICE WAS RETURNED TO OLYMPUS FOR SERVICE AND REPAIR. THE OLYMPUS SCOPE WAS SENT TO AN INDEPENDENT LABORATORY FOR CULTURE TESTING. ALL CHANNELS WERE SAMPLED AND THE CUSTOMER¿S ALLEGATION COULD NOT BE CONFIRMED. THE OBTAINED RESULTS ARE IN CONFORMANCE WITH THE REQUIREMENTS. PHYSICAL INSPECTION OF THE RETURNED DEVICE FOUND A CRACKED LIGHT GUIDE COVER LENS, A DAMAGED DISTAL CAP END, WORN GLUE ON THE BENDING SECTION RUBBER, A DEFORMED BENDING SECTION, A WORN CONNECTION PART OF BENDING SECTION AND INSERTION TUBE, A DAMAGED PROTECTOR GRIP ON THE BODY CONTROL UNIT, A WORN BODY CONTROL UNIT, A WORN SUCTION CYLINDER, AND KINKED AND BUCKLED LIGHT GUIDE TUBE. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER: HEALTH PROFESSIONAL. THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER¿S INVESTIGATION AND APPLICABLE CORRECTIONS. THE REVIEW OF THE DEVICE HISTORY RECORD (DHR) DID NOT FIND ANY ABNORMALITIES OR ANOMALIES IDENTIFIED DURING PRODUCTION. THE DEVICE MET ALL SPECIFICATIONS UPON RELEASE. ALTHOUGH THE CAUSE OF THE MICROBIOLOGICAL CONTAMINATION COULD NOT BE CONCLUSIVELY DETERMINED, THE INVESTIGATION IDENTIFIED TWO POSSIBLE CAUSES. EITHER THE REPROCESSING CONDUCTED BY THE USER DEVIATED FROM THE REPROCESSING RECOMMENDED IN THE INSTRUCTIONS FOR USE (IFU) OR THE CONTAMINATION OCCURRED DURING MICROBIOLOGICAL SAMPLING. IFU (REPROCESSING MANUAL) CAUTIONS THE USER AGAINST INSUFFICIENT REPROCESSING AS BELOW: PRECAUTIONS: WARNING: 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 THE FIELD PERFORMANCE OF THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO CORRECT THE LEGAL MANUFACTURER¿S CONTACT INFORMATION AND FACILITY REGISTRATION NUMBER. THE FACILITY REGISTRATION NUMBER IS 9610595.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED, THE EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE TESTED POSITIVE FOR KOCURIA RHIZOPHILA DURING ROUTINE TESTING. PER PROCEDURE, THE DEVICE WAS REPROCESSED AND A SECOND TEST WAS PERFORMED. THE SECOND TEST WAS POSITIVE FOR PSEUDOMONAS AERUGINOSA. THE DEVICE WAS REPROCESSED AND A THIRD TEST WAS THEN PERFORMED AND THE DEVICE TESTED POSITIVE FOR PSEUDOMONAS AERUGINOSA. THE DEVICE WAS REPROCESSED AGAIN AND AN ADDITIONAL TEST WAS PERFORMED AND THE DEVICE TESTED POSITIVE FOR ENTEROCOCCUS FAECIUM. THE LOCATION OF THE BACTERIA WAS THE INSTRUMENT CHANNEL. THE CUSTOMER HAD A BROTH MICRODILUTION TEST PERFORMED FOR BOTH PSEUDOMONAS AERUGINOSA AND ENTEROCOCCUS FAECIUM. 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
    1480725 EVIS EXERA ¿ GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS AIZU OLYMPUS CO., LTD. GIF-Q165 04953170202308

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown