BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE

    MDR report key: 12675146 · Received October 21, 2021

    Report

    Report Number
    8010047-2021-13512
    Event Type
    Malfunction
    Date Received
    October 21, 2021
    Date of Event
    September 29, 2021
    Report Date
    December 8, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    ODG
    UDI-DI
    04953170356339
    PMA / PMN Number
    K093395
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    AS PART OF OUR INVESTIGATION, WHILE ONSITE THE ESS PERFORMED A REPROCESSING IN-SERVICE WITH THE FACILITY¿S INFECTION CONTROL STAFF. THE ESS COVERED THE INFECTION CONTROL INFORMATION REFERENCED IN THE USER MANUAL AND REPROCESSING MANUAL WIT THE STAFF. THE ESS RECOMMENDED THAT THE CUSTOMER CONTACT THE AER MANUFACTURER TO OBTAIN THE PROPER USE OF THE EQUIPMENT. THE ESS ALSO RECOMMENDED THAT THE CUSTOMER USE THE PROPER BRUSHES TO CLEAN THE SCOPE. THE ESS INFORMED THE LOCAL SALES REPRESENTATIVE THAT THE CUSTOMER WOULD NEED TO ORDER THE CORRECT BRUSHES AND TO PROVIDE A QUOTE TO THE FACILITY¿S STERILE PROCESSING MANAGER. IN ADDITION, THE FACILITY¿S GI MANAGER INFORMED THE ESS THAT CASES WOULD BE CANCELLED UNTIL THE CORRECT BRUSHES ARE RECEIVED. THE ESS EMAILED A COPY OF THE ON-TRACK FORMS TO THE CUSTOMER. THE SCOPE WILL NOT BE RETURNED TO THE SERVICE CENTER FOR EVALUATION. AN INVESTIGATION IS ONGOING TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. IF ADDITIONAL INFORMATION IS RECEIVED THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. 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 CAUSE OF THE FACILITY NOT USING THE PROPER BRUSHES TO CLEAN THE SCOPE IS LIKELY DUE TO IMPROPER TRAINING ON REPROCESSING ACCORDING TO INSTRUCTIONS FOR USE. THE SPECIFIC ROOT CAUSE OF THE FACILITY USING THE INCORRECT BRUSHES COULD NOT BE DETERMINED AT THIS TIME. THE FOLLOWING INFORMATION IS STATED IN THE INSTRUCTIONS FOR USE WHICH MAY HAVE PREVENTED THE EVENT: "5.2 IMPORTANCE OF CLEANING, DISINFECTION, AND STERILIZATION. THE MEDICAL LITERATURE REPORTS INCIDENTS OF CROSS-CONTAMINATION RESULTING FROM IMPROPER CLEANING, DISINFECTION, OR STERILIZATION. IT IS STRONGLY RECOMMENDED THAT ALL INDIVIDUALS ENGAGED IN REPROCESSING CLOSELY OBSERVE ALL INSTRUCTIONS GIVEN IN THIS MANUAL AND THE MANUALS OF ALL ANCILLARY EQUIPMENT, AND HAVE A THOROUGH UNDERSTANDING OF THE FOLLOWING ITEMS: PROFESSIONAL HEALTH AND SAFETY CRITERIA OF YOUR HEALTHCARE FACILITY, INDIVIDUAL CLEANING, DISINFECTION, AND STERILIZATION PROTOCOLS, STRUCTURE AND HANDLING OF ENDOSCOPIC EQUIPMENT, HANDLING OF PERTINENT CHEMICALS. FOR THE TYPES AND CONDITIONS OF THE MEANS OF CLEANING, DISINFECTION, AND STERILIZATION TO BE ADOPTED, PLEASE MAKE JUDGMENTS FROM YOUR PROFESSIONAL VIEWPOINTS." OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    THE ENDOSCOPY SUPPORT SPECIALIST (ESS) REPORTED THAT DURING AN ONSITE REPROCESSING IN-SERVICE AT THE CUSTOMER¿S SITE, IT WAS NOTED THAT THE SCOPE WAS BEING IMPROPERLY REPROCESSED. THE ESS REPORTED THAT THE CUSTOMER WAS NOT USING THE PROPER BRUSHES TO CLEAN THE SCOPE. THE CUSTOMER USES AN AUTOMATIC ENDOSCOPE REPROCESSOR (AER) TO REPROCESS THEIR SCOPES. THERE WAS NO ASSOCIATED PATIENT INFECTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1572700 EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE ULTRASOUND GASTROVIDEOSCOPE ODG OLYMPUS MEDICAL SYSTEMS CORP. GF-UCT180 04953170356339

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown