BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III COLONOVIDEOSCOPE

    MDR report key: 14477237 · Received May 23, 2022

    Report

    Report Number
    8010047-2022-08753
    Event Type
    Malfunction
    Date Received
    May 23, 2022
    Report Date
    August 8, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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 NONPATHOGENIC BACTERIA ( 3 SPECIES ) TOTAL OF 55 CFU/100 ML). 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. BELOW ARE INFORMATION ON CUSTOMERS CDS CHECKLIST: PAA_CDS MACHINE SOLUSCOPE 4 AER/EWD REPROCESSOR: SOLUSCOPE 4; AER NOT TESTED. MODEL NAME: SOLUSCOPE 4; DETERGENT NAME: SOLUSCOPE CLN; DISINFECTANT NAME: SOLUSCOPE PAA. PRE-CLEANING: ASPIRATION OF WATER THROUGH THE INSTRUMENT / SUCTION CHANNEL , FLUSHING CHANNELS : A/W (AIR/WATER) CHANNEL, AUXILIARY CHANNEL. DETERGENT USED : FRANKLAB DDN 9; MANUAL CLEANING : FRANKLAB DDN 9; BRUSH MODEL : ALBYN MEDICAL. BRUSH POINTS: INSTRUMENT / SUCTION CHANNEL , SUCTION CYLINDER , INSTRUMENT CHANNEL PORT, DISTAL END AREAS AROUND ELEVATOR. SCOPE STORAGE: SIMPLE CABINET (NO DRYING FUNCTION), HORIZONTALLY PLACED. SCOPE REPAIR AND MAINTENANCE: BY OLYMPUS. THE RRC (REGIONAL REPAIR CENTER) FRANCE OLYMPUS FOR DEVICE EVALUATION RESULTS HAS NOT YET BEEN RECEIVED FOR EVALUATION. SUPPLEMENTAL REPORT(S) WILL BE SUBMITTED SHOULD ANY RELEVANT NEW INFORMATION IS AVAILABLE AND OR RECEIVED. INVESTIGATION IS ONGOING. THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY FOLLOWING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    CORRECTION TO E3 AND G2, OTHER HEALTH CARE PROFESSIONAL AND HEALTHCARE PROFESSIONAL WERE INADVERTENTLY SELECTED. THE REPORTER'S HEALTH CARE PROFESSIONAL STATUS WAS NOT PROVIDED. 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. MULTIPLE DEFECTS WERE NOTED WHERE: ·CHARGED COUPLED DEVICE COVER LENS SCRATCHED ·DISTAL END CAP COVER DENTED ·BENDING SECTION RUBBER GLUE DISCOLORED ·BENDING TUBE SHORTENED ·KEY TOP 1 SCRATCHED ·UNIVERSAL CORD WRINKLED ·BENDING TUBE MOVEMENT ·COIL PIPE PLATE DEFORMED HOWEVER, THESE DEFECTS ALONE ARE NOT CONSIDERED SEVERE ENOUGH TO CAUSE A POTENTIAL ADVERSE EVENT. THE LEGAL MANUFACTURE REVIEWED THE CLEANING DISINFECTION AND STERILIZATION PRACTICES OF THE USER AND NOTED THE FOLLOWING DEVIATION FROM THE DEVICE INSTRUCTIONS FOR USE (IFU): BRUSHING WAS NOT PERFORMED FOR BIOPSY CHANNEL OPENING AT 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 THE 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.

    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
    165285 EVIS EXERA III COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF OLYMPUS MEDICAL SYSTEMS CORP. CF-H185I

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown