BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA LLL COLONOVIDEOSCOPE

    MDR report key: 12754471 · Received November 4, 2021

    Report

    Report Number
    8010047-2021-14096
    Event Type
    Malfunction
    Date Received
    November 4, 2021
    Date of Event
    September 30, 2021
    Report Date
    March 31, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDF
    UDI-DI
    04953170305153
    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

    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 WHERE NO ABNORMALITIES WERE FOUND THAT COULD HAVE LED TO THE POSITIVE CULTURE. A FEW DEFECTS WERE NOTED THE MOUTHPIECE AND CHANNEL MOUNT UNIT WERE NOTED TO BE WORN BUT PASSED INSPECTION. THE BENDING SECTION RUBBER GLUE WAS PEELED OFF, THE LIGHT GUIDE LENS WAS CHIPPED, THE WATER INLET WAS LOOSENED. HOWEVER, THESE DEFECTS ARE NOT CONSIDERED SEVERE ENOUGH TO CAUSE A POTENTIAL ADVERSE EVENT. 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. THE FOLLOWING IS INCLUDED IN THE DEVICE 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."

    Additional Manufacturer Narrative · 0

    THE CLEANING, DISINFECTION, AND STERILIZATION OF THE SCOPE WAS PERFORMED BY THE CUSTOMER. THE LAST SAMPLING DATE WAS (B)(6) 2021. THERE WAS NO PATIENT INFECTION. THE SAMPLING WAS ROUTINE. THE SCOPE WAS PRECLEANED WITH DDN 9 DETERGENT BY FRANKLAB. MANUAL TREATMENT/BEDSIDE CLEANING INCLUDED ASEPT INMED (KIT/SWAB/REFERENCE (B)(4)) AND DDN 9. THE BIOPSY VALVE, AIR VALVE, AND SUCTION VALVE WERE MANUALLY DISINFECTED/STERILIZED. SOLUSCOPE 4 WAS USED AS THE AUTOMATIC ENDOSCOPE REPROCESSOR (AER) ALONG WITH SOLUSCOPE CLN DETERGENT AND SOLUSCOPE PAA DISINFECTANT. MAINTENANCE WAS PROVIDED BY OLYMPUS. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER, ALL CHANNELS WERE SAMPLED AND THE EVIS EXERA III COLONOVIDEOSCOPE TESTED POSITIVE FOR OVER ONE HUNDRED (100) COLONY FORMING UNITS (CFUS) OF MICROORGANISMS. THE ISSUE WAS FOUND DURING A ROUTINE CULTURE OF THE SCOPE. 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
    1651385 EVIS EXERA LLL COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF OLYMPUS MEDICAL SYSTEMS CORP. CF-H190L 04953170305153

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown