BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA LLL COLONOVIDEOSCOPE

    MDR report key: 14192514 · Received April 25, 2022

    Report

    Report Number
    8010047-2022-06972
    Event Type
    Malfunction
    Date Received
    April 25, 2022
    Date of Event
    March 30, 2022
    Report Date
    July 6, 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 PATIENT INFECTION. THE AUTOMATIC ENDOSCOPE REPROCESSOR (AER) WAS NOT CULTURED/TESTED. THE AIR/WATER CHANNEL AND AUXILIARY CHANNEL WERE FLUSHED WITH ANIOS DETERGENT. THERE WAS AN ASPIRATION OF WATER THROUGH THE INSTRUMENT/SUCTION CHANNEL AS WELL. THE INSTRUMENT/SUCTION CHANNEL, SUCTION CYLINDER, AND INSTRUMENT CHANNEL PORT WERE MANUALLY CLEANED WITH ANIOS CLEAN DETERGENT AND A PENTAX ISC 200-2850 BRUSH. THE SCOPE WAS NOT MANUALLY DISINFECTED. THE AER USED WAS A SOLUSCOPE ALONG WITH SOLUSCOPE CLN DETERGENT AND SOLUSCOPE PAA DISINFECTANT. THE SCOPE WAS STORED HORIZONTALLY IN A SOLUSCOPE DSC8000 DRYING CABINET. 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. FOUR (4) CFUS OF COAGULASE-NEGATIVE STAPHYLOCOCCI WERE DETECTED. THE RESULTS OBTAINED COMPLIED WITH THE TARGET LEVEL FOR AN ENDOSCOPE SUBJECTED TO HIGH LEVEL DISINFECTION AND RINSED WITH STERILE WATER. THE SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. 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 AND THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE DEVICE WAS EVALUATED. THE REPORTED ISSUE WAS NOT CONFIRMED PER THE HYGIENE MICROBIOLOGICAL INVESTIGATION. DURING INSPECTION, THE FOLLOWING ISSUES WERE NOTED: A-RUBBER GLUE SEPARATED AND WORN OUT, LIGHT GUIDE COVER LENS (3X) WAS CRACKED, LENS GLUE (3X) SHOWED SIGNS OF DISCOLORATION, CCD COVER LENS GLUE SHOWED SIGNS OF DISCOLORATION, KEY TOP 1 WITH SCRATCHED SWITCH SECTION, SWITCH BOX UNIT IS SCRATCHED, CONNECTOR PLUG UNIT IS SHAVED, AND THERE WAS KNOB PLAY AND LESS ANGULATION. 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, THE RELATIONSHIP BETWEEN THE POSITIVE CULTURE AND THE DEVICE CANNOT BE CONFIRMED. GROWTH OF MICROORGANISMS WAS FOUND THROUGH CULTURE TESTING BY THE USER AND OLYMPUS AFTER REPROCESSING. THE FOLLOWING IS INCLUDED IN THE 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 ALL CHANNELS OF THE EVIS EXERA III COLONOVIDEOSCOPE. THE SUCTION CHANNEL TESTED POSITIVE FOR ONE (1) COLONY FORMING UNIT (CFU) OF KLEBSIELLA PNEUMONIAE. THE OPERATING/BIOPSY CHANNEL TESTED POSITIVE FOR FIVE (5) CFUS OF KLEBSIELLA PNEUMONIAE AND ENTEROBACTER CLOACAE, AND THE WATER CHANNEL TESTED POSITIVE FOR ELEVEN (11) CFUS OF COAGULASE-NEGATIVE STAPHYLOCOCCI. THERE WAS NO 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
    184202 EVIS EXERA LLL COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF OLYMPUS MEDICAL SYSTEMS CORP. CF-H190I 04953170305177

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown