BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 18695429 · Received February 13, 2024

    Report

    Report Number
    9610595-2024-03013
    Event Type
    Malfunction
    Date Received
    February 13, 2024
    Date of Event
    January 23, 2024
    Report Date
    June 10, 2024
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDS
    UDI-DI
    04953170305276
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE NEW INFORMATION OBTAINED DURING THE DEVICE EVALUATION. ADDITIONALLY, H4 DEVICE MANUFACTURER DATE WAS ADDED. THE EVALUATION FOUND THAT THE AIR/WATER CYLINDER, JET TUBE, AND AIR/WATER TUBE ALL HAD FOREIGN OBJECTS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTION TO B3 THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON FURTHER FOLLOW-UP WITH THE USER FACILITY. THE LEGAL MANUFACTURERS (LM) REVIEW OF THE CUSTOMER CLEANING, DISINFECTION, AND STERILIZATION (CDS) PROCESSES, THE RESULTS OF THIRD-PARTY TESTING, AND THE LMS FINAL INVESTIGATION.DURING FURTHER FOLLOW-UP WITH THE USER FACILITY IT WAS NOTED THAT THE SUBJECT DEVICE WAS USED ON A TOTAL OF 4 PATIENTS WHILE AWAITING THE POSITIVE CULTURE RESULTS. MFR #'S 09021 (1/3), 08673 (2/3), 09029 (3/3) HAVE BEEN OPENED TO ADDRESS THE ADDITIONAL 3 PATIENTS.THE LM REVIEWED THE CUSTOMER-PROVIDED CDS PROCESSES, AND NO OBVIOUS DEVIATIONS FROM THE INSTRUCTIONS FOR USE (IFU) WERE IDENTIFIED.THE USER FACILITY PROVIDED THE FOLLOWING RESULT OF THE CULTURE TEST PERFORMED AT THE THIRD-PARTY LABS:SAMPLING DATE: JANUARY 23, 2024SAMPLING FROM: SUCTION CHANNEL, INSTRUMENT CHANNELCFU: >100 CFU/20 MLBACTERIAL IDENTIFICATION: SERRATIA MARCESCENS, KLEBSIELLA PNEUMONIAE, STENOTROPHOMONAS MALTOPHILIA, AND PSEUDOMONAS AERUGINOSASAMPLING DATE: JANUARY 26, 2024SAMPLING FROM: SUCTION CHANNEL, INSTRUMENT CHANNELCFU: >100 CFU/20 MLBACTERIAL IDENTIFICATION: KLEBSIELLA PNEUMONIAECFU: 12 CFU/20 MLBACTERIAL IDENTIFICATION: PSEUDOMONAS AERUGINOSACFU: >100 CFU/20 MLBACTERIAL IDENTIFICATION: STENOTROPHOMONAS MALTOPHILIASAMPLING FROM THE AUXILIARY WATER CHANNELCFU: 5 CFU/20 MLBACTERIAL IDENTIFICATION: STENOTROPHOMONAS MALTOPHILIA, GRAM-POSITIVE BACILLUS (POSSIBLY CELLULOSIMICROBIUM SP.)SAMPLING DATE: 2024/02/06SAMPLING FROM: DISTAL END UNIT, INSTRUMENT, BIOPSY, SUCTION CHANNEL, AIR/WATER CHANNEL, AUXILIARY WATER CHANNELCFU: NO DETECTIONBACTERIAL IDENTIFICATION: N/AA 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, FOR THE EVENT OF POSITIVE IN CULTURE TESTING IT IS LIKELY THAT THAT REPROCESSING WAS CONDUCTED INSUFFICIENTLY ON SUCTION CHANNEL AND BIOPSY CHANNEL. REGARDING AUXILIARY WATER CHANNEL, POSSIBILITY OF INSUFFICIENT REPROCESSING DUE TO RESIDUE AT DETECTION OF BACTERIA COULD NOT BE DENIED. GROWTH OF MICROORGANISMS WERE FOUND THROUGH CULTURE TESTING BY THE USER AFTER REPROCESSING. HOWEVER, WHEN OLYMPUS CULTURE TESTED AFTER REPROCESSING IN ACCORDANCE WITH THE IFU BEFORE REPAIR, THE RESULTS CONFORMED TO THE REGULATION'S RECOMMENDATION. FOR THE EVENT OF FOREIGN MATERIAL REMAINED, THE FOREIGN MATERIAL COULD NOT BE IDENTIFIED AND A ROOT CAUSE COULD NOT BE DETERMINED.THE DEVICE BEING USED WHILE AWAITING RESULTS OF CULTURE TESTING MAY HAVE OCCURRED DUE TO A DIFFERENCE IN RECOGNITION BETWEEN THE RECOMMENDATION BY OLYMPUS AND THE USER FACILITY ON DEVICE HANDLING AND REPROCESSING STEPS.THE FOLLOWING IS INCLUDED IN THE DEVICE IFU: "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

    THE SUSPECT DEVICE HAS NOT YET BEEN RETURNED TO OLYMPUS FOR EVALUATION AND THE INVESTIGATION IS ONGOING AND FOLLOW UP WITH THE CUSTOMER IS CURRENTLY BEING PERFORMED. THE PHYSICAL DEVICE EVALUATION HAS NOT BEEN COMPLETED. PRIOR TO THE DEVICE EVALUATION, THE DEVICE WAS SENT OUT FOR ADDITIONAL MICROBIOLOGICAL TESTING. THE MICROBIOLOGICAL ANALYSIS RESULTS ARE PENDING. THE HYGIENE MICROBIOLOGICAL INVESTIGATION REPORT INDICATED THE CHANNELS OF THE SCOPE WERE CULTURED AND NO DETECTIONS WERE FOUND. THE RESULTS OBTAINED COMPLY WITH THE TARGET LEVEL FOR AN ENDOSCOPE SUBJECTED TO HIGH LEVEL DISINFECTION AND RINSED WITH STERILE WATER. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH DEVICE EVALUATION RESULTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VIDEOSCOPE TESTED POSITIVE FOR AN UNEXPECTED CONTAMINATION. 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
    806315 EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS AIZU OLYMPUS CO., LTD. GIF-HQ190 04953170305276

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown