BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA LLL COLONOVIDEOSCOPE

    MDR report key: 14192586 · Received April 25, 2022

    Report

    Report Number
    8010047-2022-06974
    Event Type
    Malfunction
    Date Received
    April 25, 2022
    Date of Event
    March 8, 2022
    Report Date
    August 4, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDF
    UDI-DI
    04953170305177
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE CLEANING, DISINFECTION, AND STERILIZATION (CDS) OF THE SCOPE WAS PERFORMED BY THE CUSTOMER. THERE WAS NO REPORTED PATIENT INFECTION. THE AUTOMATIC ENDOSCOPE REPROCESSOR (AER) WAS CULTURED/TESTED. THE TEST RESULTS WERE NOT AVAILABLE. THE AIR/WATER CHANNEL AND AUXILIARY CHANNEL WERE FLUSHED WITH STERILE WATER. THERE WAS AN ASPIRATION OF WATER THROUGH THE INSTRUMENT/SUCTION CHANNEL AS WELL. THE INSTRUMENT/SUCTION CHANNEL, SUCTION CYLINDER, INSTRUMENT CHANNEL PORT, AND DISTAL END/AREAS AROUND THE ELEVATOR WERE MANUALLY CLEANED WITH ASEPT INMED DETERGENT AND A PENTAX ISC 200-2850 BRUSH. THE AER USED WAS A SOLUSCOPE ALONG WITH SOLUSCOPE CLN DETERGENT AND SOLUSCOPE PAA DISINFECTANT. THE SCOPE WAS STORED IN A SACHET IN A PLASMATYPHOON. THE MAINTENANCE OF THE SCOPE WAS PERFORMED BY OLYMPUS. THE SCOPE WAS NOT STERILIZED. AFTER THE DEVICE WAS RETURNED TO OLYMPUS, IT WAS SENT OUT FOR ADDITIONAL TESTING. THE HYGIENE MICROBIOLOGICAL INVESTIGATION REPORT INDICATED THE CHANNELS, AND THE DISTAL END OF THE SCOPE WERE CULTURED. ONE (1) CFU OF COAGULASE-NEGATIVE STAPHYLOCOCCI WAS DETECTED. THE RESULTS OBTAINED COMPLIED WITH THE TARGET LEVEL FOR AN ENDOSCOPE SUBJECTED TO HIGH LEVEL DISINFECTION AND RINSED WITH STERILE WATER. THE DEVICE WAS EVALUATED. THE REPORTED ISSUE WAS NOT CONFIRMED PER THE HYGIENE MICROBIOLOGICAL INVESTIGATION. DURING INSPECTION, IT WAS NOTED THE PLASTIC DISTAL END COVER HAD A SCRATCH. THE BENDING SECTION COVER GLUE HAD SEPARATED. THE CONNECTOR PLUG UNIT HAD DAMAGED HOUSING. THE ANGULATIONS WERE OUT OF SPECIFICATION. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED 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 SAME GERMS WERE NOT DETECTED. THE FOLLOWING IS INCLUDED IN THE DEVICE INSTRUCTIONS FOR USE (IFU): "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 FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER, A ROUTINE MICROBIOLOGICAL CULTURE WAS PERFORMED ON THE EVIS EXERA III COLONOVIDEOSCOPE. ON (B)(6) 2024, ALL CHANNELS TESTED POSITIVE FOR SEVEN (7) COLONY FORMING UNITS (CFUS) OF PSEUDOMONAS AERUGINOSA. ON (B)(6) 2022, THE SUCTION CHANNEL TESTED POSITIVE FOR TWENTY-SIX (26) CFUS OF PSEUDOMONAS AERUGINOSA. THERE WAS NO REPORTED CONTAMINATION OR ANY OTHER SERIOUS DETERIORATION IN THE 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
    795113 EVIS EXERA LLL COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF OLYMPUS MEDICAL SYSTEMS CORP. CF-H190I 04953170305177

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown