BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 14862168 · Received June 29, 2022

    Report

    Report Number
    8010047-2022-11077
    Event Type
    Malfunction
    Date Received
    June 29, 2022
    Report Date
    October 18, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDS
    UDI-DI
    04953170202308
    PMA / PMN Number
    K011151
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE WAS RECEIVED AND EVALUATED AT RRC (REGIONAL REPAIR CENTER ) OLYMPUS SPAIN OIB. SERVICE NOTED , THE CDS PROCESS WAS FOLLOWED AND THE DEVICE WAS CDS (CLEANING, DISINFECTION, & STERILIZATION) AND STERILIZED BY MATCHANA, NO CULTURES WERE PERFORMED. DEVICE EVALUATION AND INSPECTION FOUND NO PROBLEM WITH THE DEVICE AND PASSED ALL THE REQUIRED TESTING INCLUDING THE ELECTRICAL SAFETY TEST. 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

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE CUSTOMER PROVIDED CLEANING DISINFECTION AND SANITIZATION (CDS) PRACTICES AND THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE USER PROVIDED THEIR CDS PRACTICES OF THE SUBJECT DEVICE WHERE THE DETERGENT USED FOR PRE-CLEANING IS ANIOSYME JET PLUS. THE STEPS PERFORMED IN PRE-CLEANING ARE ASPIRATION OF WATER THROUGH THE INSTRUMENT / SUCTION CHANNEL, AND FLUSHING THE AIR / WATER CHANNEL. THE BRUSHED POINTS ARE THE INSTRUMENTS / SUCTION CHANNEL, THE SUCTION CYLINDER, THE INSTRUMENT CHANNEL PORT, AND THE DISTAL END / AREAS AROUND ELEVATOR. THE DEVICE IS MANUALLY PROCESSED WITH A NOVA CLEAN CJ-EBD-230-06 CLEANING BRUSH. THE MANUAL DISINFECTION WAS NOT PERFORMED. THE MODEL NAME OF AER / EWD AND CHEMICALS USED ARE AS FOLLOWS: MODEL NAME: ETD-3, ETD-4; DETERGENT NAME: ENDEDET, ENDOACT; DISINFECTANT NAME: ENDODIS. THE ENDOSCOPE WAS STORED VERTICALLY IN AN EDC PLUS DRYING CABINET. THE MAINTENANCE WAS PERFORMED BY OLYMPUS. 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 AND BECAUSE THE EVENT WAS NOT CONFIRMED, THE RELATION BETWEEN THE EVENT AND THE DEVICE COULD NOT BE CONFIRMED. 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, CUSTOMER PERFORMED ROUTINE MICROBIOLOGICAL TESTS TO RANDOM ENDOSCOPES AND IDENTIFIED CONTAMINATION IN THIS ENDOSCOPE IN THE ASPIRATION CHANNEL. THE ASPIRATION CHANNEL TESTED POSITIVE WITH >5000 COLONIES KLEBSIELLA, CITROBACTER. ACCORDING TO REPORTER, THERE HAVE BEEN NO PATIENTS INFECTED. THERE IS NO PATIENT INFECTION ASSOCIATED ON THIS EVENT REPORTED. THERE WAS NO PATIENT HARM, NO USER INJURY REPORTED. THIS REPORTED EVENT INCLUDES 3 REPORTS. (B)(6) MODEL CF-Q165L SN (B)(4) COLONOVIDEOSCOPE : 28 COLONIES (CITROBACTER,TROFOMONAS ) (B)(6) MODEL CF-Q165L SN (B)(4) COLONOVIDEOSCOPE : >5000 COLONIES (ENETROCOCO, KLEBSIELLA, CITROBACTER, ETC.) (B)(6) MODEL GIF-Q165 SN (B)(4) GASTROVIDEOSCOPE : >5000 COLONIES (KLEBSIELLA, CITROBACTER) THIS REPORT IS FOR (B)(6) MODEL GIF-Q165 SN (B)(4) GASTROVIDEOSCOPE : >5000 COLONIES (KLEBSIELLA, CITROBACTER) .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2473388 EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS OLYMPUS MEDICAL SYSTEMS CORP. GIF-Q165 04953170202308

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown