BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 14781614 · Received June 22, 2022

    Report

    Report Number
    8010047-2022-10609
    Event Type
    Malfunction
    Date Received
    June 22, 2022
    Date of Event
    May 29, 2022
    Report Date
    October 11, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDS
    UDI-DI
    04953170202285
    PMA / PMN Number
    K100584
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER PROVIDED THE CDS CHECKLIST WITH THE HMI (HYGIENE MICROBIOLOGICAL INVESTIGATION) RESULTS. CDS CHECKLIST NOTED NO PATIENT INFECTION. CUSTOMER NOTED NO CONTAMINANTS WERE FOUND IN THE MACHINE (AER/EWD) REPROCESSOR. THE CUSTOMER HMI (HYGIENE MICROBIOLOGICAL INVESTIGATION) RESULTS REPORTED THE DEVICE TESTED POSITIVE WITH MICROORGANISM WITH THE FOLLOWING: SAMPLING POINT DATE: NAME OF MICROORGANISMS FOUND PER CFU(S)/ML: (B)(6) 2022 ACINETOBACTER BAUMANNII 300 CFU/ML; (B)(6) 2022 CANDIDA PARAPSILOSIS 2 CFU/ML; (B)(6) 2022 CANDIDA PARAPSILOSIS, STENOTROPHOMONAS MALTOPHILIA, ACINETOBACTER BAUMANNII, ACHROMOBACTER XYLOSOXIDANS 100 CFU/ML; (B)(6) 2022 NO IDENTIFICATION 1 CFU/ML; (B)(6) 2011 EN (B)(6) 2022; (B)(6) 2022 CANDIDA PARAPSILOSIS 1 CFU/ML; (B)(6) 2022 PSEUDOMONAS AERUGINOSA, KLEBSIELLA PNEUMONIAE, ACINETOBACTER BAUMANNII 23 CFU/ML; (B)(6) 2022 PSEUDOMONAS AERUGINOSA, KLEBSIELLA PNEUMONIAE, ACHROMOBACTER XYLOSOXIDANS 150 CFU/ML; (B)(6) 2022 KLEBSIELLA PNEUMONIAE, ACINETOBACTER BAUMANNII, STENOTROPHOMONAS MALTOPHILIA 150 CFU/ML. BELOW ARE INFORMATION ON CUSTOMERS CDS CHECKLIST: AER/EWD REPROCESSOR: TESTED; MODEL NAME: WASSENBURG; DETERGENT NAME: ENDOHIGH DETERGENT; DISINFECTANT NAME: ENDOHIGH PAA. 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: MULTIZYME (EVAT PROTEASE , LIPASE, AMYLASE), BUITENKANT WORDT GEREINIGD MET INTERCEPT WIPES). MANUAL CLEANING : DETERGENT; ENZIMED PREVENT VAN ONELIFE. BRUSH POINTS: INSTRUMENT / SUCTION CHANNEL , SUCTION CYLINDER , INSTRUMENT CHANNEL PORT, BALLOON CHANNEL, DISTAL END AREAS AROUND ELEVATOR. BRUSH MODEL: RED BRUSH PULL THRU STUBBY BRUSH , LUMEN CHANNEL: PULL THRU. ENDOSCOPE WAS NOT STERILIZED. SCOPE STORAGE: HORIZONTALLY PLACED. DRYING WITH PLASMA TYPHOON AND STORAGE IN PLACE. SCOPE MAINTENANCE: BY OLYMPUS. THE OLYMPUS SUBSIDIARY FOR HMI (HYGIENE MICROBIOLOGICAL INVESTIGATION) RESULTS HAS NOT BEEN RECEIVED. SUPPLEMENTAL REPORT(S) WILL BE SUBMITTED SHOULD ANY RELEVANT NEW INFORMATION IS AVAILABLE. 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 DEVICE WAS NOT RETURNED TO OLYMPUS FOR INSPECTION OR TESTING. NO DEVIATIONS FROM THE INSTRUCTIONS FOR USE WERE IDENTIFIED FROM THE REVIEW OF THE REPROCESSING STEPS PROVIDED FROM THE USER. 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, THE RELATIONSHIP BETWEEN THE POSITIVE CULTURE AND THE DEVICE CANNOT BE CONFIRMED. GROWTH OF MICROORGANISMS WAS FOUND THROUGH CULTURE TESTING BY THE USER AFTER REPROCESSING. SINCE OLYMPUS DID NOT CONDUCT ADDITIONAL MICROBIAL TESTING, AND THE DEVICE WAS NOT RETURNED, THE ROOT CAUSE CANNOT BE IDENTIFIED. THE FOLLOWING IS INCLUDED IN THE INSTRUCTIONS FOR USE (IFU): "AN INSUFFICIENTLY REPROCESSED ENDOSCOPE AND/OR ACCESSORY MAY POSE AN INFECTION CONTROL RISK TO THE PATIENTS AND/OR OPERATORS WHO TOUCH THEM."

    Description of Event or Problem · 0

    AS REPORTED, CUSTOMER REPORTED CHANNEL IS CONTAMINATED. THE ISSUE FOUND DURING REPROCESSING. THERE IS NO PATIENT INFECTION ASSOCIATED ON THIS REPORTED EVENT. THERE WAS NO PATIENT HARM REPORTED. NO USER INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1240644 EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS OLYMPUS MEDICAL SYSTEMS CORP. GIF-H180 04953170202285

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown