BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE

    MDR report key: 12843683 · Received November 19, 2021

    Report

    Report Number
    8010047-2021-14826
    Event Type
    Malfunction
    Date Received
    November 19, 2021
    Date of Event
    October 5, 2021
    Report Date
    April 6, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    ODG
    UDI-DI
    04953170287879
    PMA / PMN Number
    K093395
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE OLYMPUS SCOPE WAS SENT TO AN INDEPENDENT LABORATORY FOR CULTURE TESTING AND THE RESULTS ARE PENDING. THE CUSTOMER PROVIDED INFORMATION REGARDING HOW ENDOSCOPES ARE CLEANED, DISINFECTED AND STERILIZED ONSITE. DURING PRE-CLEANING, THE CUSTOMER USES THE DETERGENT FRANKLAB DDN 9. DURING MANUAL CLEANING, THE CUSTOMER USES DETERGENT FRANKLAB DDN 9 AND DISINFECTANTS ANIOXYDE 1000, PERACETIC ACID AND GLUTARALDEHYDE. THE CUSTOMER MANUALLY CLEANS THE BIOPSY, AIR AND SUCTION VALVES ON THE SCOPE. THE CUSTOMER USES AUTOMATED ENDOSCOPE REPROCESSOR (AER) SOLUSCOPE 4, ALONG WITH DETERGENT SOLUSCOPE CLN AND SOLUSCOPE PAA. 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 DEVICE EVALUATION, THE LEGAL MANUFACTURER'S FINAL INVESTIGATION AND THE HYGIENE MICROBIOLOGICAL INVESTIGATION REPORT. AFTER THE DEVICE WAS RETURNED TO OLYMPUS, IT WAS SENT OUT FOR ADDITIONAL TESTING. THE HYGIENE MICROBIOLOGICAL INVESTIGATION REPORT INDICATED THE CHANNELS OF THE SCOPE WERE CULTURED AND TESTED POSITIVE WITH NINE (9) COLONY FORMING UNITS (CFUS) OF GRAM-POSITIVE BACTERIA AND IDENTIFIED COAGULASE-NEGATIVE STAPHYLOCOCCI. AFTER BEING REPROCESSED A SECOND TIME PER THE INSTRUCTIONS FOR USE (IFU) AND SENT OUT FOR ADDITIONAL TESTING, THE MICROBIOLOGICAL ANALYSIS REPORT INDICATED THE CHANNELS OF THE SCOPE WERE CULTURED AND RESULTS OBTAINED COMPLY WITH THE TARGET LEVEL FOR AN ENDOSCOPE SUBJECTED TO HIGH LEVEL DISINFECTION AND RINSED WITH STERILE WATER. THE DEVICE WAS EVALUATED WHERE NO ABNORMALITIES WERE FOUND THOUGH THERE WERE SEVERAL TECHNICAL DEFECTS SUCH AS THE BENDING SECTION COVER GLUE IS PEELING OFF, THERE WAS KNOB PLAY AND LESS ANGULATION, THE PROTECTOR PLUG UNIT WAS DAMAGED AND A SHORT CHARGED COUPLED DEVICE WIRE. THESE DEFECTS WERE NOT CONSIDERED SEVERE ENOUGH TO CAUSE A POTENTIAL ADVERSE EVENT AND ARE LIKELY DUE TO WEAR AND TEAR DAMAGE FROM USE OVER AN EXTENDED PERIOD OF TIME. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 9 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, THE RELATION BETWEEN THE EVENT AND THE DEVICE COULD NOT BE CONFIRMED. THOUGH LOWER THAN THAT STANDARD VALUE, GROWTH WAS CONFIRMED AFTER REPROCESSING IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). THIS INFORMATION IS ADDRESSED IN THE INSTRUCTIONS FOR USE (IFU): "WARNING: THOROUGHLY CLEAN AND HIGH-LEVEL DISINFECT OR STERILIZE THE ENDOSCOPE BEFORE RETURNING IT FOR REPAIR. IMPROPERLY REPROCESSED EQUIPMENT POSES AN INFECTION CONTROL RISK TO EACH PERSON WHO HANDLES THE ENDOSCOPE WITHIN THE HOSPITAL OR AT OLYMPUS." OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS, THE EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE TESTED POSITIVE FOR OVER 100 COLONY FORMING UNITS (CFUS) OF AN UNIDENTIFIED GRAM-POSITIVE BACTERIA. THE ISSUE WAS FOUND DURING A ROUTINE CULTURE OF THE SCOPE, WHICH HAD OCCURRED DURING REPROCESSING. 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
    1741759 EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE ULTRASOUND GASTROVIDEOSCOPE ODG OLYMPUS MEDICAL SYSTEMS CORP. GF-UCT180 04953170287879

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown