BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE

    MDR report key: 23722961 · Received December 4, 2025

    Report

    Report Number
    3002808148-2025-24260
    Event Type
    Malfunction
    Date Received
    December 4, 2025
    Date of Event
    October 10, 2025
    Report Date
    February 17, 2026
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    ODG
    UDI-DI
    04953170287879
    PMA / PMN Number
    K093395
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE APPROVED FINAL INVESTIGATION. BASED ON THE RESULTS OF THE INVESTIGATION, AND SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION, THE DEFINITIVE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER.

    Description of Event or Problem · 0

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED ¿ULTRASOUND ENDOSCOPES AND ROUTINE MICROBIOLOGICAL SURVEILLANCE - ANOTHER CRITICAL DEVICE IN REPROCESSING¿. BACKGROUND: PERIODIC ROUTINE MICROBIOLOGICAL SURVEILLANCE OF GASTROINTESTINAL ENDOSCOPES IS RECOMMENDED TO ENSURE ADEQUACY OF REPROCESSING. WE AIMED TO INVESTIGATE WHETHER THERE WERE DIFFERENCES IN CONTAMINATION DEPENDING ON THE TYPE OF ENDOSCOPE. METHODS: WE ANALYZED 437 MICROBIOLOGICAL SURVEILLANCE SAMPLES OBTAINED FROM GASTROINTESTINAL ENDOSCOPES AT A TERTIARY-CARE CENTER IN SWITZERLAND. SAMPLING WAS CARRIED OUT AFTER REPROCESSING IN WASHER-DISINFECTORS ACCORDING TO STANDARD SN (B)(6). FOR MICROBIOLOGICAL ANALYSIS, ENDOSCOPE IRRIGATION SOLUTION WAS FILTERED AND TRANSFERRED TO SHEEP BLOOD AGAR. THESE PLATES WERE INCUBATED AT 37°C. IF BACTERIAL GROWTH WAS DETECTED, THE SPECIES WAS IDENTIFIED USING MALDI OR OTHER MICROBIOLOGICAL IDENTIFICATION TECHNIQUES, AND COLONY FORMING UNITS (CFUS) WERE COUNTED. CONTAMINATION WAS DEFINED AS DETECTION OF ANY MICROORGANISM WITH =20 CFUS/20 ML OR DETECTION OF ENTEROBACTERALES, ENTEROCOCCUS SPP., PSEUDOMONAS AERUGINOSA AND OTHER NON-FERMENTERS, STREPTOCOCCUS VIRIDANS AND STAPHYLOCOCCUS AUREUS, INDEPENDENT OF CFU COUNT. RESULTS: TOTALLY, 204 SAMPLES WERE GATHERED FROM 28 GASTROSCOPES, 146 SAMPLES FROM 23 COLONOSCOPES, 45 SAMPLES FROM 5 ULTRASOUND ENDOSCOPES, 27 FROM 4 DUODENOSCOPES AND 15 FROM 3 ENTEROSCOPES, RESPECTIVELY. ELEVEN (2.5%) SAMPLES, GATHERED FROM 5 ENDOSCOPES, INDICATED CONTAMINATION. THE PROPORTION OF SAMPLES INDICATING CONTAMINATION VARIED LARGELY BY ENDOSCOPE TYPE: 20.0% (9/45) OF ULTRASOUND ENDOSCOPES-DERIVED, 1.4% (2/146) OF COLONOSCOPE-DERIVED, 0.5% (1/204) OF GASTROSCOPE-DERIVED, 0% (0/27) OF DUODENOSCOPE-DERIVED AND 0% (0/15) ENTEROSCOPE-DERIVED SAMPLES WERE CONTAMINATED (P<0.001). CONCLUSIONS: OVERALL, A SMALL PROPORTION OF ENDOSCOPES WERE CONTAMINATED. SIGNIFICANT DIFFERENCES WERE OBSERVED BASED ON THE TYPE OF ENDOSCOPE, WITH ULTRASOUND ENDOSCOPES PERFORMING WORST. EVENT 1: ENDOSCOPE SAMPLES INDICATING CONTAMINATION (1) GIF-1TH190 (EVENT 1) REFER TO TABLE1 AS FOLLOWS (ENDOSCOPE NUMBER 1) DATE (B)(6). 2021, SUCTION CHANNEL, STAPHYLOCOCCUS AUREUS <=1 (CFU/ML) (2) GF-UE160-AL5 (EVENT 1) REFER TO TABLE1 AS FOLLOWS (ENDOSCOPE NUMBER 2) DATE (B)(6) 2021, BIOPSY CHANNEL, CANDIDA PARAPSILOSIS >100000 (CFU/ML) DATE (B)(6) 2021, AIR/WATER CHANNEL, CANDIDA PARAPSILOSIS 25 (CFU/ML) DATE (B)(6) 2021, AIR/WATER CHANNEL, CANDIDA PARAPSILOSIS 55-60 (CFU/ML) DATE (B)(6) 2021, SUCTION CHANNEL, CANDIDA PARAPSILOSIS 25 (CFU/ML) (3) GF-UCT180 (EVENT 1) REFER TO TABLE1 AS FOLLOWS (ENDOSCOPE NUMBER 3) DATE (B)(6) 2021, AIR/WATER CHANNEL, CANDIDA PARAPSILOSIS 20 (CFU/ML) DATE (B)(6) 2021, SUCTION CHANNEL, CANDIDA PARAPSILOSIS 100 (CFU/ML) DATE (B)(6) 2021, AIR/WATER CHANNEL, CANDIDA PARAPSILOSIS 20 (CFU/ML) DATE (B)(6) 2021, SUCTION CHANNEL, CANDIDA PARAPSILOSIS 35 (CFU/ML) (4) GF-UE160-AL5 (EVENT 1) REFER TO TABLE1 AS FOLLOWS (ENDOSCOPE NUMBER 4) DATE (B)(6) 2021, AIR/WATER CHANNEL, CANDIDA PARAPSILOSIS 7000 (CFU/ML) (5)PCF-H190DL (EVENT 1) REFER TO TABLE1 AS FOLLOWS (ENDOSCOPE NUMBER 5) DATE (B)(6) 2021, AIR/WATER CHANNEL, STAPHYLOCOCCUS EPIDERMIS 1 (CFU/ML) ENTEROCOCCUS FAECALIS 1 (CFU/ML). THIS IS REPORT 3 OF 5 FOR: GF-UCT180 DATE (B)(6) 2021, AIR/WATER CHANNEL, CANDIDA PARAPSILOSIS 20 (CFU/ML). DATE (B)(6) 2021, SUCTION CHANNEL, CANDIDA PARAPSILOSIS 100 (CFU/ML). DATE (B)(6) 2021, AIR/WATER CHANNEL, CANDIDA PARAPSILOSIS 20 (CFU/ML). DATE (B)(6) 2021, SUCTION CHANNEL, CANDIDA PARAPSILOSIS 35 (CFU/ML).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157819 EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE ULTRASOUND GASTROVIDEOSCOPE ODG SHIRAKAWA OLYMPUS CO., LTD. GF-UCT180 04953170287879

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown