BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA LLL COLONOVIDEOSCOPE

    MDR report key: 13500372 · Received February 9, 2022

    Report

    Report Number
    8010047-2022-02681
    Event Type
    Malfunction
    Date Received
    February 9, 2022
    Report Date
    April 29, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDF
    UDI-DI
    04953170305177
    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

    THE CUSTOMER HMI (HYGIENE MICROBIOLOGICAL INVESTIGATION) RESULTS AND THE OFR (OLYMPUS FRANCE) FRENCH OLYMPUS SUBSIDIARY FOR HMI (HYGIENE MICROBIOLOGICAL INVESTIGATION) HAS NOT YET BEEN RECEIVED FOR EVALUATION. BELOW ARE INFORMATION ON CUSTOMERS CDS CHECKLIST: CDS: PAA_CDS MACHINE ETD3 / ETD4. MANUAL: BRUSH ¿ ASEPT-INMED REF 201792. ENDODET - THE DETERGENT USED FOR CLEANING. ENDODIS - THE DISINFECTANT USED FOR DISINFECTION. STORAGE: SCOPE ARRANGEMENT HORIZONTAL. 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 DEVICE EVALUATION, CUSTOMERS PROVIDED HMI CULTURE RESULTS, OFR THIRD PARTY CULTURE RESULTS. THE FOLLOWING SECTIONS WERE UPDATED. THE CUSTOMER HMI (HYGIENE MICROBIOLOGICAL INVESTIGATION) RESULTS THE DEVICE TESTED POSITIVE FOR FORTY (40) COLONY FORMING UNITS (CFUS) OF MICROORGANISMS. 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 OFR HMI (HYGIENE MICROBIOLOGICAL INVESTIGATION) RESULTS REPORTED THE ENDOSCOPE DEVICE CHANNEL (ALL CHANNELS) CONFORMS. ONE (1) COLONY FORMING UNIT (CFU) OF MICROCOCCACEAE WAS IDENTIFIED. 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. RRC (REGIONAL REPAIR CENTER) FRANCE OLYMPUS DEVICE EVALUATION FINDINGS ARE BELOW: LIGHT GUIDE COVER LENS FOUND CRACKED. THE A-RUBBER GLUE WAS SEPARATED, CUT ON KEY TOP FOUND AND ANGULATIONS ARE OUT OF SPECIFICATIONS. INVESTIGATIONS ARE ONGOING. THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY FOLLOWING INVESTIGATION COMPLETION.

    Additional Manufacturer Narrative · 0

    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. 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.

    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
    102376 EVIS EXERA LLL COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF OLYMPUS MEDICAL SYSTEMS CORP. CF-H190I 04953170305177

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown