BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OES CYSTONEPHROFIBERSCOPE

    MDR report key: 15097810 · Received July 25, 2022

    Report

    Report Number
    3002808148-2022-00280
    Event Type
    Malfunction
    Date Received
    July 25, 2022
    Date of Event
    June 24, 2022
    Report Date
    September 20, 2022
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD
    Product Code
    FAJ
    UDI-DI
    04953170338496
    PMA / PMN Number
    K032092
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER PROVIDED THE HMI (HYGIENE MICROBIOLOGICAL INVESTIGATION) RESULTS. THE CUSTOMER HMI (HYGIENE MICROBIOLOGICAL INVESTIGATION) RESULTS REPORTED THE ENDOSCOPE DEVICE CHANNEL (ALL CHANNELS) TESTED POSITIVE WITH THE FOLLOWING MICROORGANISM: MICROCOCCUS LUTEUS / STAPHYLOCOCCUS HOMINIS (2 IDENTIFICATIONS NOTED) WITH RESULTS OF 3 CFU/100ML. THE OFR (OLYMPUS FRANCE) FRENCH OLYMPUS SUBSIDIARY FOR HMI (HYGIENE MICROBIOLOGICAL INVESTIGATION) PERFORMED A CULTURE TEST FOR THE DEVICE AFTER THE DEVICE WAS REPROCESSED THE RESULTS REPORTED THE ENDOSCOPE DEVICE CHANNEL (ALL CHANNELS) CONFORMS TO RESULTS OF REVIVABLE MICRO-ORGANISMS LESS THAN 1 CFU/100 ML AND LESS THAN 1 CFU/ENDOSCOPE . THE RESULTS OBTAINED COMPLY WITH THE TARGET LEVEL DEFINED IN THE REGULATIONS OF FRANCE OUTLINED ON JULY 4, 2016. THE RESULTS ARE CONFORM TO FRENCH RECOMMENDATION. THE DEVICE WAS THEN RETURNED TO RRC (REGIONAL REPAIR CENTER) FRANCE OLYMPUS FOR DEVICE EVALUATION. THE DEVICE INSPECTION AND EVALUATION FINDINGS NOTED BELOW: DEVICE INSPECTION DURING INCOMING INSPECTION FOUND NO DAMAGE OR ISSUES. DEVICE WAS TESTED AND PASSED REQUIRED SPECIFICATIONS . SERVICE NOTED PRODUCT WAS SENT BACK TO THE CUSTOMER WITH NO REPAIR PERFORMED AS NO ISSUES OBSERVED. BELOW ARE INFORMATION ON CUSTOMERS CDS CHECKLIST: CDS: PAA_MANUAL TREATMENT AER/EWD REPROCESSOR: N/A. MODEL NAME: N/A. DISINFECTANT NAME: N/A. PRE-CLEANING: ASPIRATION OF WATER THROUGH THE INSTRUMENT/SUCTION CHANNEL. FLUSHING CHANNELS : A/W CHANNEL, AUXILIARY WATER CHANNEL, BALLOON CHANNEL , FORCEPS ELEVATOR WIRE CHANNEL. DETERGENT USED : ANIOS CLEAN EXCEL D. MANUAL CLEANING : BRUSH POINTS: INSTRUMENT / SUCTION CHANNEL , SUCTION CYLINDER , INSTRUMENT CHANNEL PORT, BALLOON CHANNEL, DISTAL END AREAS AROUND ELEVATOR. BRUSH MODEL: LTA EBI-1824/25. MANUAL DISINFECTION PERFORMED. DISINFECTANT USED: ANIOXYDE 1000. SCOPE : STERILIZED WITH HYDROGEN PEROXIDE. FREQUENCY OF STERILIZATION: ONE (1) TIME. STERILIZATION EQUIPMENT MODEL : VPROMAX 2. SCOPE STORAGE: SIMPLE CABINET WITHOUT ANY DRYING FUNCTION. HORIZONTALLY PLACED. SCOPE MAINTENANCE : BY OLYMPUS. INVESTIGATION IS ONGOING. THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY FOLLOWING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE LEGAL MANUFACTURE REVIEWED THE USERS CLEANING DISNFECTION AND STERILIZATION PROCESSES WHERE IT WAS NOTED THAT ACETIC ACID WAS USED FOR MANUAL CLEANING. 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: IMPROPERLY REPROCESSED EQUIPMENT POSES AN INFECTION CONTROL RISK TO EACH PERSON WHO HANDLES THE ENDOSCOPE WITHIN THE HOSPITAL OR AT OLYMPUS." OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    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 OFR (OLYMPUS FRANCE) FRENCH OLYMPUS SUBSIDIARY FOR HMI (HYGIENE MICROBIOLOGICAL INVESTIGATION) FOR FURTHER INVESTIGATION. THE USER DID NOT REPORT ANY CONTAMINATION OR ANY PATIENT INJURY OR PATIENT INFECTION TO WHICH THIS MEDICAL DEVICE COULD HAVE BEEN A CONTRIBUTORY CAUSE. NO USER INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    968282 OES CYSTONEPHROFIBERSCOPE CYSTONEPHROFIBERSCOPE FAJ SHIRAKAWA OLYMPUS CO., LTD CYF-5 04953170338496

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown