BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EUS ULTRASOUND GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 16344902 · Received February 9, 2023

    Report

    Report Number
    3002808148-2023-01272
    Event Type
    Malfunction
    Date Received
    February 9, 2023
    Date of Event
    November 9, 2022
    Report Date
    April 18, 2023
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    ODG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION FROM THE AUTHOR (SEE B5). ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH DEVICE EVALUATION RESULTS.

    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. THE DEVICE HISTORY RECORD WAS UNABLE TO BE REVIEWED FOR THIS DEVICE SINCE THE SERIAL AND/OR LOT NUMBER WAS NOT PROVIDED. HOWEVER, OLYMPUS ONLY RELEASES PRODUCTS TO MARKET THAT MEET ALL MANUFACTURING SPECIFICATIONS AND FINAL PRODUCT RELEASE CRITERIA. BASED ON THE RESULTS OF THE INVESTIGATION, THE RELATIONSHIP BETWEEN THE DEVICE AND THE ADVERSE EVENT CANNOT BE CONFIRMED. THERE WAS NO COMPLAINT REPORTED ON THE SUBJECT DEVICE. THERE IS NO EVIDENCE OF AN OLYMPUS DEVICE MALFUNCTION. THEREFORE, THE ROOT CAUSE CANNOT BE DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, THE ENDOSCOPE/ACCESSORY CULTURE RESULTS WERE POSITIVE AND THERE WERE NO PATIENT INFECTIONS NOTED.

    Description of Event or Problem · 0

    OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "NEW CLEANING METHOD AND ITS EFFECTS REVISED FROM THE EVALUATION OF CLEANLINESS OF GASTROINTESTINAL ENDOSCOPE". OUR CENTER PERFORMS CLEANING IN ACCORDANCE WITH THE CLEANING MANUAL. CONFIRM THE CLEANING EFFECT OF THIS METHOD. FOR FREQUENTLY USED SCOPES GIF-H290T, GF-UCT260, GF-UE290, JF-260V, EG-L600ZW7, EC-600ZP7, EG-L580NW7 AND ACCESSORIES, AFTER USE, CULTURE TESTS OF GENERAL BACTERIA AND CLEANLINESS EVALUATION WERE PERFORMED USING 3M'S ATP MEASURING INSTRUMENT LUMINOMETER NGI. ONE CULTURE TEST AND TWO ATP MEASUREMENTS WERE PERFORMED FOR EACH SCOPE. THE SURVEY SITES WERE THE TIP OF THE SCOPE, THE SUCTION PIPELINE, THE AIR SUPPLY PIPELINE, THE WATER PIPELINE, THE FORCEPS LIFTING WIRE PIPE, THE BALLOON AIR SUPPLY PIPELINE AND THE ACCESSORIES SUCH AS THE SUCTION BUTTON AND THE AIR SUPPLY / WATER SUPPLY BUTTON. AS A RESULT OF CULTURE TEST, P. ACNES WAS DETECTED IN THE SUCTION PIPE OF JF-260V, PSEUDOMONAS AERUGINOSA IN THE AIR PIPE OF EG-L580NW7, CORYNEBACTERIUS FROM THE SUCTION BUTTON AND STAPHYLOCOCCUS AUREUS FROM THE AIR SUPPLY / WATER SUPPLY BUTTON OF THE ULTRASOUND ENDOSCOPE, AND NON-FERMENTING GLUCOSE BACTERIA FROM THE SUCTION BUTTON OF THE GENERAL-PURPOSE SCOPE. BY EVALUATING THE DEGREE OF CLEANING, IT BECAME CLEAR THAT IT WAS NECESSARY TO REVIEW THE CURRENT METHOD. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS. ACNE BACTERIA STAPHYLOCOCCUS AUREUS GLUCOSE NON-FERMENTATIVE BACTERIA THIS LITERATURE ARTICLE REQUIRES 4 REPORTS. THE RELATED PATIENT IDENTIFIERS ARE AS FOLLOWS: (B)(6)/GIF-H290T. (B)(6)/GF-UCT260. (B)(6)/GF-UE290. (B)(6)/JF-260V. THIS MEDWATCH REPORT IS FOR PATIENT IDENTIFIER (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43901 EVIS EUS ULTRASOUND GASTROINTESTINAL VIDEOSCOPE ULTRASOUND GASTROVIDEOSCOPE ODG SHIRAKAWA OLYMPUS CO., LTD. GF-UE290

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown