BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE

    MDR report key: 16960884 · Received May 19, 2023

    Report

    Report Number
    3002808148-2023-05028
    Event Type
    Malfunction
    Date Received
    May 19, 2023
    Date of Event
    April 19, 2023
    Report Date
    July 16, 2023
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    ODG
    UDI-DI
    04953170356346
    PMA / PMN Number
    K093395
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO AN OLYMPUS REPAIR FACILITY, AND AN EVALUATION WAS PERFORMED. UPON INSPECTION AND TESTING OF THE UNIT, THE AIR/WATER CHANNEL WAS CLOGGED, PREVENTING AIR AND WATER FROM FEEDING INTO THE CHANNEL. OLYMPUS WAS UNABLE TO DETERMINE THE MATERIAL CAUSING THE CLOGGING AND WAS UNABLE TO REMOVE IT. IN ADDITION, A NOZZLE UNIT WAS MISSING; A WORN FE LEVER PREVENTED THE UP/DOWN KNOB FROM LOCKING SECURELY; A WORN ANGLE WIRE, AND A SCRAPED OBJECTIVE LENS WERE DISCOVERED. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    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 REPORTED STICKY GLUE-LIKE MATERIAL CLOGGING THE CHANNEL, NOZZLE AND AIR/WATER CHANNEL COULD NOT BE IDENTIFIED. A DEFINITIVE ROOT CAUSE OF THE ISSUE COULD NOT BE DETERMINED, HOWEVER, DUE TO THE OBSERVED DEVICE DAMAGE/ BUCKLING OF EACH CHANNEL OR NOZZLE / THE GAP ON THE INSERTION SECTION OR THE BOOT, IT IS LIKELY THAT THE REPROCESSING COULD NOT BE PROPERLY COMPLETED. THE EVENT MAY BE PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE SECTIONS BELOW: CHAPTER 6 COMPATIBLE REPROCESSING METHODS AND CHEMICAL AGENTS CHAPTER 7 CLEANING, DISINFECTION, AND STERILIZATION PROCEDURES. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE CHANNEL AND NOZZLE WERE CLOGGED WITH A STICKY, GLUE-LIKE SUBSTANCE. IT WAS SUSPECTED THAT IT OCCURRED DUE TO A REMEDY USED DURING A PROCEDURE AFTER WHICH THE REMAINS WERE NOT PROPERLY REMOVED. SUBSEQUENTLY, THE SCOPE NO LONGER PASSED THE FLOW CONTROL OF THE ENDOTHERM DISINFECTORS ETD DOUBLE AUTOMATIC ENDOSCOPIC REPROCESSOR (ETDD). THERE WAS NO REPORT OF PATIENT OR USER INJURY DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623106 EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE ULTRASOUND GASTROVIDEOSCOPE ODG SHIRAKAWA OLYMPUS CO., LTD. GF-UCT180 04953170356346

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown