BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE

    MDR report key: 15092240 · Received July 25, 2022

    Report

    Report Number
    3002808148-2022-00263
    Event Type
    Malfunction
    Date Received
    July 25, 2022
    Date of Event
    June 22, 2022
    Report Date
    November 7, 2022
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    ODG
    UDI-DI
    04953170356339
    PMA / PMN Number
    K093395
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE CLEANING, DISINFECTION, AND STERILIZATION (CDS) OF THE SCOPE WAS PERFORMED BY THE CUSTOMER. THERE WAS NO PATIENT INFECTION. THE AUTOMATIC ENDOSCOPE REPROCESSOR (AER) WAS CULTURED/TESTED, HOWEVER THE RESULTS WERE NOT AVAILABLE. THE AIR/WATER CHANNEL, AUXILIARY CHANNEL, BALLOON CHANNEL, AND FORCEPS ELEVATOR CHANNEL WERE FLUSHED. THE SCOPE WAS PRECLEANED WITH FRANKLAB DDN 9 DETERGENT. THERE WAS AN ASPIRATION OF WATER THROUGH THE INSTRUMENT/SUCTION CHANNEL AS WELL. THE INSTRUMENT/SUCTION CHANNEL, SUCTION CYLINDER, BALLOON CHANNEL, AND INSTRUMENT CHANNEL PORT AND DISTAL END/AREAS AROUND THE ELEVATOR WERE MANUALLY CLEANED WITH ANIOSYME 5 SYNERGY DETERGENT AND ASEPT INMED (REFERENCE #(B)(4)) AND OLYMPUS BRUSHES. THE SCOPE WAS NOT MANUALLY DISINFECTED. THE AER USED WAS A SOLUSCOPE 4 ALONG WITH SOLUSCOPE CLN DETERGENT AND SOLUSCOPE PAA DISINFECTANT. THE SCOPE WAS STORED HORIZONTALLY. THE MAINTENANCE OF THE SCOPE WAS PERFORMED BY OLYMPUS. THE SCOPE WAS NOT STERILIZED. THE SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. THE INVESTIGATION IS ONGOING; THEREFORE, THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED AT THIS TIME. HOWEVER, IF ADDITIONAL INFORMATION BECOMES AVAILABLE 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. THE DEVICE WAS EVALUATED WHERE IT WAS FOUND THAT THERE WERE SCRATCHES INSIDE THE AIR/WATER AND SUCTION CYLINDERS AND MOUNT, THE PROBE SURFACE WAS DAMAGED & OTHER WEAR AND TEAR ELEMENTS WERE PRESENT. THE ADDITIONAL COUNTRY TESTING RESULTS DID NOT CONFORM WITH 10 COLONY FORMING UNITS FOUND. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 1 YEAR SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THAT REPROCESSING WAS INSUFFICIENT DUE TO PHYSICAL DAMAGE TO THE DEVICE. A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED. THIS INFORMATION IS ADDRESSED IN THE INSTRUCTIONS FOR USE (IFU): "¦CHAPTER 6 COMPATIBLE REPROCESSING METHODS AND CHEMICAL AGENTS. ¦CHAPTER 7 CLEANING, DISINFECTION, AND STERILIZATION PROCEDURES". OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS, A ROUTINE MICROBIOLOGICAL CULTURE WAS PERFORMED ON THE EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE. THE CHANNEL TESTED POSITIVE FOR TWO (2) COLONY FORMING UNITS (CFUS) OF SPHINGOMONAS PAUCIMOBILIS AND ALLOIOCOCCUS OTITIS. THE FORCEPS ELEVATOR TESTED POSITIVE FOR THREE (3) CFUS OF SPHINGOMONAS PAUCIMOBILIS AND ALLOIOCOCCUS OTITIS. THERE WAS NO CONTAMINATION OR ANY OTHER SERIOUS DETERIORATION IN THE STATE OF HEALTH OF ANY PERSON, TO WHICH THE SCOPE COULD HAVE BEEN A CONTRIBUTORY CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88306 EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE ULTRASOUND GASTROVIDEOSCOPE ODG SHIRAKAWA OLYMPUS CO., LTD. GF-UCT180 04953170356339

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown