BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 12749612 · Received November 3, 2021

    Report

    Report Number
    8010047-2021-14034
    Event Type
    Malfunction
    Date Received
    November 3, 2021
    Date of Event
    September 27, 2021
    Report Date
    February 17, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDS
    UDI-DI
    04953170307515
    PMA / PMN Number
    K100584
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON CUSTOMER HMI (HYGIENE MICROBIOLOGICAL INVESTIGATION) RESULTS , OFR (OLYMPUS FRANCE) FRENCH OLYMPUS SUBSIDIARY FOR HMI (HYGIENE MICROBIOLOGICAL INVESTIGATION) RESULTS, CUSTOMER CDS CHECKLIST . THE CUSTOMER HMI (HYGIENE MICROBIOLOGICAL INVESTIGATION) RESULTS REPORTED THE DEVICE TESTED POSITIVE WITH PSEUDOMONAS AERUGINOSA AND E. COLI (120 CFU). BELOW ARE INFORMATION ON CUSTOMERS CDS CHECKLIST: CDS MACHINE : AER WASSENBURG. MEDICLEAN FORTE -THE DETERGENT USED FOR CLEANING ENDOSEPT PAC - THE DISINFECTANT USED FOR DISINFECTION. STORAGE: PLASMATYPHOON. THE OFR (OLYMPUS FRANCE) FRENCH OLYMPUS SUBSIDIARY FOR HMI (HYGIENE MICROBIOLOGICAL INVESTIGATION) PERFORMED A CULTURE TEST FOR THE DEVICE AFTER THE DEVICE WAS REPROCESSED . SAMPLING RESULTS ON (B)(6) 2021 : HMI CHU COUNTRY MICROBIOLOGICAL RESULTS NON CONFORM. THE HMI COUNTRY SAMPLING SHOWS A NON CONFORM RESULT TO FRENCH REGULATION. CULTURE RESULTS DETECTED CHAMPIGNONS FILAMENTEUX (5 CFU). SCOPE REPROCESSED AND SECOND SAMPLING PERFORMED ON (B)(6) 2021. THE OFR HMI (HYGIENE MICROBIOLOGICAL INVESTIGATION) RESULTS REPORTED THE ENDOSCOPE DEVICE CHANNEL (ALL CHANNELS) CONFORMS, WITH RESULTS 1 FCU. OFR (OLYMPUS FRANCE) FRENCH OLYMPUS SUBSIDIARY FOR HMI (HYGIENE MICROBIOLOGICAL INVESTIGATION) RESULTS OBTAINED COMPLY WITH THE TARGET LEVEL DEFINED IN THE REGULATIONS OF FRANCE OUTLINED ON (B)(6) 2016. THE RESULTS ARE CONFORM TO FRENCH RECOMMENDATION. RRC (REGIONAL REPAIR CENTER) FRANCE OLYMPUS DEVICE EVALUATION FINDINGS NOTED DURING INCOMING INSPECTION FOUND (BENDING SECTION) A-RUBBER GLUING PEEL OFF. INVESTIGATION IS ONGOING. THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY FOLLOWING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    CORRECTION TO B3, THE EVENT DATE WAS 27SEP2021. CORRECTION TO G2 TO ADD THE FOREIGN COUNTRY FRANCE. ADDITIONAL INFORMATION ADDED TO D9, PRODUCT RETURN DATE WAS 13DEC2021. THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE DEVICE WAS EVALUATED WHERE NO ABNORMALITIES WERE FOUND THAT COULD HAVE LED TO THE POSITIVE CULTURE. THE USERS CLEANING DISINFECTION AND SANITIZATION PRACTICES WERE REVIEWED BY THE LEGAL MANUFACTURE AND IT WAS NOTED THAT THE USER DID NOT PERFORM ALCOHOL FLUSHING INTO THE CHANNELS AT STERILIZATION AS RECOMMENDED BY THE INSTRUCTIONS FOR USE (IFU). 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, IT IS UNLIKELY THE POSITIVE CULTURE WAS CAUSED BY THE DEVICE. 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. THE FOLLOWING IS INCLUDED IN THE 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." "RINSE WATER: WHEN NONSTERILE WATER IS USED AFTER DISINFECTION, WIPE THE ENDOSCOPE AND FLUSH THE CHANNELS WITH 70% ETHYL OR ISOPROPYL ALCOHOL, THEN AIR-DRY ALL INTERNAL CHANNELS TO INHIBIT THE GROWTH OF BACTERIA. DO NOT REUSE RINSE WATER."

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE CUSTOMERS HMI (HYGIENE MICROBIOLOGICAL INVESTIGATION) RESULTS AND (B)(4) (OLYMPUS (B)(4)) OLYMPUS SUBSIDIARY FOR HMI (HYGIENE MICROBIOLOGICAL INVESTIGATION) RESULTS HAS NOT YET BEEN RECEIVED FOR EVALUATION. INVESTIGATION IS ONGOING. THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY FOLLOWING INVESTIGATION.

    Description of Event or Problem · 0

    AS REPORTED, AFTER A MICROBIOLOGICAL ROUTINE CONTROL TEST ON THE SUBJECT MEDICAL DEVICE AS REQUIRED BY FRENCH REGULATION, THE USER DETECTED AN UNEXPECTED CONTAMINATION. THE ISSUE FOUND DURING REPROCESSING. THE USER THEN SENT THE DEVICE TO THE (B)(4) OLYMPUS SUBSIDIARY FOR HMI (HYGIENE MICROBIOLOGICAL INVESTIGATION) FOR FURTHER INVESTIGATION. THE USER DID NOT REPORT ANY CONTAMINATION OR ANY PATIENT INJURY OR PATIENT INFECTION. NO USER INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1641016 EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS OLYMPUS MEDICAL SYSTEMS CORP. GIF-XP180N 04953170307515

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown