BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II DUODENOVIDEOSCOPE

    MDR report key: 20659892 · Received November 11, 2024

    Report

    Report Number
    9610595-2024-40016
    Event Type
    Malfunction
    Date Received
    November 11, 2024
    Date of Event
    September 23, 2024
    Report Date
    March 31, 2025
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDT
    UDI-DI
    04953170367311
    PMA / PMN Number
    K143153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR INSPECTION AND THEREFORE THE REPORTED FAILURE WAS CONFIRMED. BASED ON THE RESULTS OF THE INVESTIGATION, AND THE DEVICE NOT BEING RETURNED, A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    IT IS CURRENTLY UNKNOWN WHICH OF THE 16 OLYMPUS SCOPES USED IN THE STUDY SPECIFICALLY TESTED POSITIVE FOR MICROBIAL CONTAMINATION. THIS REPORT IS RELATED TO THE FOLLOWING LINKED PATIENT IDENTIFIERS: (B)(6). THE EVALUATION OF THE EVENT IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS RECEIVED FROM CUSTOMER.

    Description of Event or Problem · 0

    OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "A NEW DRYING METHOD OF THERMOLABILE FLEXIBLE ENDOSCOPE CHANNELS BY LAMINAR AND TURBULENT AIRFLOW ¿ A PROSPECTIVE, RANDOMIZED-CONTROLLED, SINGLE-CENTER, PROOF-OF-CONCEPT TRIAL." LITERATURE SUMMARY: ABSTRACT. BACKGROUND AND AIMS: INTERNATIONAL GUIDELINES SUGGEST DIFFERENT POSSIBILITIES FOR DRYING OF ENDOSCOPES DURING REPROCESSING. CLINICAL RESULTS OF THESE AVAILABLE DRYING METHODS ARE NOT SATISFACTORY. THE AIM OF THIS STUDY WAS TO COMPARE THE DRYING CYCLE OF A STANDARD ENDOSCOPE WASHER-DISINFECTOR (EWD) (STANDARD DRYING METHOD [SD]) WITH A SHORTENED MANDATORY DRYING BY THE EWD FOLLOWED BY A SPECIAL DRYING DEVICE USING LAMINAR AND TURBULENT AIR FLOW (NOVEL DRYING METHOD [ND]). MATERIALS AND METHODS: SIXTY ENDOSCOPES (DUODENOSCOPES, COLONOSCOCOPES AND GASTROSCOPES) FROM THREE DIFFERENT MANUFACTURERS UNDERWENT HIGH-LEVEL DISINFECTION AND DRYING DEPENDING ON THE RANDOMIZATION GROUP. OPERATIONAL TIME OF DRYING WAS MEASURED FOR BOTH GROUPS. RESIDUAL FLUID IN THE CHANNELS WAS MEASURED USING A LABORATORY SCALE. AFTER A 14 DAY STORAGE PERIOD, A SAMPLE OF THE ENDOSCOPE CHANNELS WAS OBTAINED TO DETERMINE BACTERIAL CONTAMINATION. RESULTS: ND HAD SIGNIFICANTLY FEWER RESIDUAL WATER IN ENDOSCOPE CHANNELS (SD: 90% VS ND: 0%; P < 0.001) AFTER HIGH-LEVEL DISINFECTION AND DRYING, AND LESS BACTERIAL CONTAMINATION AFTER STORAGE FOR 14 DAYS (SD: 47% VS ND: 20%; P = 0.028). TIME CONSUMED FOR DRYING IN ND WAS ALSO SIGNIFICANTLY SHORTER (SD: 16MIN 4SEC VS ND: 5MIN 59SEC; P < 0.001). CONCLUSIONS: DRYING WITH A SPECIAL AUTOMATIC DRYING DEVICE WAS SUPERIOR COMPARED WITH AN EWD¿S DRYING PROGRAM AS EVIDENCED BY NO MEASURABLE RESIDUAL WATER, REDUCED MICROBIOLOGICAL CONTAMINATION AND A MORE THAN TWO-FOLD DECREASE IN OPERATIONAL TIME. THUS, DRYING BY LAMINAR AND TURBULENT AIRFLOW MAY REPRESENT AN ATTRACTIVE ALTERNATIVE TO THE CURRENTLY USED STANDARD APPROACH IN THE REPROCESSING PROCESS OF FLEXIBLE ENDOSCOPES. MICROBIOLOGICAL ANALYSIS AFTER 14 DAYS OF STORAGE: MICROBIOLOGICAL CONTAMINATION WAS SIGNIFICANTLY LOWER IN ND (6, 20%) COMPARED TO SD (14, 47%) (P = 0.03; OR: 0.29 [95%-CI: 0.09 ¿ 0.90]; ARR: 27% [95%-CI: 3 ¿ 47%]; RRR: 57% [95%-CI: 4 ¿ 81%]; NNT: 3.75 [95%-CI: 2 ¿ 36]). ALSO, THE NUMBER OF CFU/CHANNELS WAS SIGNIFICANTLY LOWER IN ND (0.6 ± 1.3) COMPARED TO SD (3.7 ± 14.3) (P = 0.046). OF THE SIX ENDOSCOPES CONTAMINATED IN ND, FOUR (67%) CONTAINED ONE BACTERIAL SPECIES AND TWO (33%) HAD TWO DIFFERENT SPECIES. IN SD, 11 ENDOSCOPES WERE CONTAMINATED BY ONE (79%), TWO ENDOSCOPES BY TWO (14%) AND ONE ENDOSCOPE BY FOUR (7%) DIFFERENT BACTERIAL SPECIES, RESPECTIVELY. ONLY THE ONE ENDOSCOPE WITH FOUR DIFFERENT BACTERIAL SPECIES IN SD (PENTAX COLONOSCOPE) HAD A TOTAL OF 78 CFU/CHANNELS. ALL OTHER CONTAMINATIONS RANGED BETWEEN 2 TO 4 CFU/CHANNELS. IN A SUBGROUP ANALYSIS, PENTAX ENDOSCOPES HAD SIGNIFICANTLY FEWER BACTERIAL STRAINS IN ND (1 ,7%; 0.13 ± 0.52) COMPARED TO SD (8, 50%; 6.19 ± 19.48) (P = 0.02). FUJIFILM, OLYMPUS, DUODENOSCOPES, COLONOSCOPES AND GASTROSCOPES DID NOT DIFFER SIGNIFICANTLY BETWEEN BOTH GROUPS (TABLE 1). IN AN EXPLORATORY SUBGROUP ANALYSIS DUODENOSCOPES WITH AND WITHOUT REMOVABLE CAP WERE COMPARED. IN SD, TWO DUODENOSCOPES WITH REMOVABLE CAP (40%) AND TWO DUODENOSCOPES (67%) WITHOUT REMOVABLE CAP WERE FOUND TO BE CONTAMINATED (P > 0.05). IN ND, ALL SIX DUODENOSCOPES WITH REMOVABLE CAP HAD NO CONTAMINATION (0%), WHEREAS ALL FOUR DUODENOSCOPES WITHOUT REMOVABLE CAP (100%) SHOWED CONTAMINATION (P < 0.01). DRYING AND RESIDUAL FLUID: ALL CHANNELS, REGARDLESS OF ENDOSCOPE TYPE OR MANUFACTURER WERE COMPLETELY DRY AFTER REPROCESSING IN ND. IN SD, 27 (90%) ENDOSCOPES HAD RESIDUAL FLUID (0.86 G ± 1.53 G). BOTH GROUPS WERE SIGNIFICANTLY DIFFERENT FOR BOTH QUANTITATIVE ANALYSIS (P < 0.001) AND QUALITATIVE ANALYSIS (P < 0.001). IN A SUBGROUP ANALYSIS, SD WAS SIGNIFICANTLY INFERIOR TO ND FOR EACH TYPE OF ENDOSCOPE AND ALL THREE COMPANIES. (TABLE 2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1513282 EVIS EXERA II DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT AIZU OLYMPUS CO., LTD. TJF-Q180V 04953170367311

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown