BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 12957765 · Received December 7, 2021

    Report

    Report Number
    8010047-2021-15693
    Event Type
    Malfunction
    Date Received
    December 7, 2021
    Date of Event
    November 10, 2021
    Report Date
    April 26, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDS
    UDI-DI
    04953170307539
    PMA / PMN Number
    K051645
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE CUSTOMER HMI (HYGIENE MICROBIOLOGICAL INVESTIGATION) , OFR HMI AND DEVICE EVALUATION RESULTS. THE CUSTOMER HMI (HYGIENE MICROBIOLOGICAL INVESTIGATION) RESULTS REPORTED AS BELOW: MICROORGANISM AEROBIES (21 CFU/100 ML) 3 AND 5 DAYS CULTURE AND PRESENCE OF PSEUDOMONAS SPP; CUSTOMER PERFORMED INTERMEDIATE DISINFECTION RINSING WITH EBM - PRESENCE OF MICROORGANISM INDICATORS; TOTAL OF GREATER THAN 25 FCU; AFTER HIGH LEVEL DISINFECTION - PRESENCE OF MICROORGANISM INDICATORS; TOTAL LESS THAN 1 CFU. 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) CONFORM, WITH RESULTS OF LESS THAN 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 JULY 4, 2016. THE RESULTS ARE CONFORM TO FRENCH RECOMMENDATION. RRC (REGIONAL REPAIR CENTER) FRANCE OLYMPUS DEVICE EVALUATION FINDINGS ARE BELOW: BIOPSY CHANNEL EXCHANGE AS PREVENTIVE MAINTENANCE. CHANNEL CLEANING BRUSH PASSAGE USING NJ4072 IS CORRECT WITHOUT FEELING ANY DIFFICULTY. ALL CHANNELS ARE CLEAN AND FREE FROM FOREIGN MATERIAL. BIOPSY CHANNEL AIR-LEAK, LG LENS CHIPPED, CCD LENS WITH DISCOLORATION, C-COVER DENT, A-RUBBER GLUING WORN OUT, CONNECTING TUBE WRINKLED, LG TUBE WRINKLED, WEAR ON SWITCH #1. INVESTIGATION IS ONGOING. THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY FOLLOWING COMPLETION OF INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION AND CORRECTION TO G2. G2 - CHECKED "OTHER" TO ADD THE COUNTRY FRANCE. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 7 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, THE RELATION BETWEEN THE EVENT AND THE DEVICE COULD NOT BE CONFIRMED. THOUGH LOWER THAN THAT STANDARD VALUE, GROWTH WAS CONFIRMED AFTER REPROCESSING IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). THIS INFORMATION IS ADDRESSED IN THE INSTRUCTIONS FOR USE (IFU): "REPROCESSING MANUAL: 1.4 PRECAUTIONS: 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 THE FIELD PERFORMANCE OF THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER HMI (HYGIENE MICROBIOLOGICAL INVESTIGATION) RESULTS HAS NOT YET BEEN RECEIVED FOR EVALUATION. BELOW ARE INFORMATION ON CUSTOMERS CDS CHECKLIST: MANUAL TREATMENT. CHEMICAL : ENZYMEX (FRANKLAB) BRUSH : MEDICA BRUSH, ALBIN MEDICAL 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
    1854863 EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS OLYMPUS MEDICAL SYSTEMS CORP. GIF-H180J 04953170307539

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown