BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA ELITE GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 16429315 · Received February 23, 2023

    Report

    Report Number
    9610595-2023-03085
    Event Type
    Malfunction
    Date Received
    February 23, 2023
    Date of Event
    January 8, 2023
    Report Date
    April 24, 2023
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION IS IN PROCESS. THE LITERATURE ARTICLE IS ATTACHED FOR ADDITIONAL INFORMATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH DEVICE EVALUATION RESULTS.

    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. IT HAS BEEN OVER 7 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, THE RELATIONSHIP BETWEEN THE DEVICE AND THE ADVERSE EVENT CANNOT BE CONFIRMED. THERE IS NO EVIDENCE OF AN OLYMPUS DEVICE MALFUNCTION. THEREFORE, THE ROOT CAUSE CANNOT BE DETERMINED. THIS SUPPLEMENTAL REPORT INCLUDES A CORRECTION TO B5 TO PROVIDE INFORMATION THAT WAS INADVERTENTLY NOT INCLUDED ON THE INITIAL MEDWATCH. ALSO, INFORMATION HAS BEEN ADDED TO D8. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED "EFFECT OF AN AUTOMATED FLEXIBLE ENDOSCOPE CHANNELS BRUSHING SYSTEM ON IMPROVING REPROCESSING QUALITY: A RANDOMIZED CONTROLLED STUDY." BACKGROUND AND STUDY AIMS: QUALIFIED REPROCESSING, OF WHICH METICULOUS CHANNELS BRUSHING IS THE MOST CRUCIAL STEP, IS ESSENTIAL FOR PREVENTION AND CONTROL OF ENDOSCOPY-ASSOCIATED INFECTIONS. HOWEVER, CHANNELS BRUSHING IS OFTEN OMITTED IN PRACTICE. THIS STUDY AIMED TO EVALUATE THE EFFECT OF AN AUTOMATED FLEXIBLE ENDOSCOPE CHANNELS BRUSHING SYSTEM (AECBS) ON IMPROVING THE QUALITY OF ENDOSCOPE REPROCESSING. METHODS: THIS PROSPECTIVE, RANDOMIZED CONTROLLED STUDY WAS CONDUCTED, BETWEEN NOV 24, 2021 AND JAN 22, 2022, AT RENMIN HOSPITAL OF WUHAN UNIVERSITY, CHINA. ELIGIBLE ENDOSCOPES WERE RANDOMLY ALLOCATED TO THE AUTO GROUP (CHANNELS BRUSHED BY AECBS) OR THE MANUAL GROUP (CHANNELS BRUSHED MANUALLY), WITH SAMPLING AND CULTURING AFTER HIGH-LEVEL DISINFECTION AND DRYING. THE PRIMARY ENDPOINT WAS THE PROPORTION OF POSITIVE CULTURES FOR ENDOSCOPES. RESULTS: 204 ENDOSCOPES IN THE AUTO GROUP AND 205 IN THE MANUAL GROUP WERE EVENTUALLY ANALYZED. THE PROPORTION OF POSITIVE CULTURES WAS SIGNIFICANTLY LOWER IN THE AUTO GROUP (15.2% [95% CI 10.7-21.0%])) THAN IN THE MANUAL GROUP (23.4% [95% CI 17.9-29.9%]). CONCLUSIONS: AECBS COULD EFFECTIVELY REDUCE BIOBURDEN AND IMPROVE REPROCESSING QUALITY OF GASTROSCOPES AND COLONOSCOPES. IT HAS GREAT POTENTIAL TO REPLACE MANUAL BRUSHING AND LOWER THE RISK OF ENDOSCOPY-ASSOCIATED INFECTIONS, PROVIDING A NEW IDEA FOR THE OPTIMIZATION OF REPROCESSING. POSITIVE IN CULTURE TEST - 79. OF THE 79 POSITIVE IN CULTURE TESTS, 34 OLYMPUS SCOPES WERE REPORTED TO OLYMPUS. THIS LITERATURE ARTICLE REQUIRES 34 REPORTS. THE RELATED PATIENT IDENTIFIERS ARE AS FOLLOWS: (B)(6) GIF-XQ260/2035124. (B)(6) CF-Q260AI/2914692. (B)(6) GIF-Q260 /2251882. (B)(6) GIF-Q260 /2251880. (B)(6) GIF-XQ260/2522612. (B)(6) GIF-XQ260/2522683. (B)(6) GIF-XQ260/2135577. (B)(6) CF-Q260AI/2316718. (B)(6) GIF-HQ290/2512845. (B)(6) GIF-XQ260/2345963. (B)(6) GIF-H290/2523634. (B)(6) GIF-HQ290/2513476. (B)(6) CF-H290I/ 2500920. (B)(6) CF-H290I/2500915. (B)(6) GIF-H260/2557771. (B)(6) GIF-HQ290/2857287. (B)(6) GIF-HQ290/2857264. (B)(6) CF-HQ290I/2854046. (B)(6) CF-HQ290I/2854035. (B)(6) GIF-HQ290/2858329. (B)(6) CF-HQ290I/2854501. (B)(6) GIF-HQ290/2746295. (B)(6) GIF TYPE H260/2768996. (B)(6) CF-HQ290I/2743299. (B)(6) GIF TYPE H260/2769049. (B)(6) GIF TYPE H260/2769054. (B)(6) GIF-HQ290/2960370. (B)(6) GIF-HQ290/2960372. (B)(6) GIF-HQ290/2960314. (B)(6) GIF-HQ290/2960278. (B)(6) CF-HQ290I/2955422. (B)(6) CF-HQ290I/2955421. (B)(6) CF-HQ290I/2955424. (B)(6) CF-HQ290I/2955411. THIS MEDWATCH REPORT IS FOR PATIENT IDENTIFIER (B)(6). THERE WAS NO HUMAN SUBJECT INVOLVED IN THE STUDY.

    Description of Event or Problem · 0

    IT WAS CONFIRMED THAT THERE WAS NO OLYMPUS DEVICE MALFUNCTION. IN ADDITION, AN OLYMPUS DEVICE DID NOT CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449431 EVIS LUCERA ELITE GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS AIZU OLYMPUS CO., LTD. GIF-HQ290

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown