BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS EUS ULTRASOUND GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 13862563 · Received March 23, 2022

    Report

    Report Number
    8010047-2022-04836
    Event Type
    Injury
    Date Received
    March 23, 2022
    Report Date
    April 26, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    ODG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. THE DEVICE HISTORY RECORD WAS UNABLE TO BE REVIEWED FOR THIS DEVICE SINCE THE SERIAL 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. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) REVIEWED A LITERATURE TITLED "CLINICAL RESULTS OF EUS INTRODUCTION AT OUR HOSPITAL." BACKGROUND / PURPOSE FROM OCTOBER 2020, WE INTRODUCED ENDOSCOPIC ULTRASONOGRAPHY (EUS) (OLYMPUS GF-UE290) AT OUR HOSPITAL. WE WILL INVESTIGATE THE MEDICAL RESULTS OF EUS INTRODUCED AT OUR HOSPITAL, AND EXAMINE AND REPORT ON THE BENEFITS TO PATIENTS IN THE SUBSEQUENT REGIONAL COOPERATION. METHODS: THE SUBJECTS WERE 81 CASES AND 71 CASES WHO UNDERWENT EUS FROM OCTOBER 2020 TO SEPTEMBER 2021. WE INVESTIGATED THE BACKGROUND OF PATIENTS WHO UNDERWENT EUS, THE PURPOSE OF EUS EXAMINATION, THE NUMBER OF CONTRASTS, THE NUMBER OF FINENEEDLE ASPIRATIONS UNDER EUS (HEREINAFTER REFERRED TO AS EUS-FNA), AND COMPLICATIONS. WE ALSO EXAMINED CASES IN WHICH THE BENEFITS OF EUS EXAMINATION WERE CONSIDERED TO HAVE BEEN OBTAINED. RESULTS: THE AVERAGE AGE WAS 73 YEARS, 56 FOR MEN AND 25 FOR WOMEN. THE PURPOSE OF EUS EXAMINATION WAS 25 CASES OF BILE DUCT LESION EXAMINATION, 49 CASES OF PANCREATIC LESION EXAMINATION, 4 CASES OF GASTRIC SUBMUCOSAL TUMOR EXAMINATION, AND 5 CASES OF INTRA-ABDOMINAL MASS EXAMINATION. THERE WERE 14 CASES OF EUS-FNA AND 7 CASES OF EUS CONTRAST-ENHANCED ULTRASONOGRAPHY. THE COMPLICATIONS WERE BLEEDING IN 1 CASE AND SEDATION DISINHIBITION IN 1 CASE. CASES IN WHICH EUS WAS INTRODUCED AND ESPECIALLY BENEFITED WERE CASES IN WHICH MALIGNANT TUMOR WAS DIAGNOSED BY EUS OR FNA AND PROCEEDED TO TREATMENT, CASES IN WHICH MALIGNANT TUMOR WAS DENIED BY EUS-FNA, AND EUS NOT VISUALIZED BY CT OR MRI. THERE WERE 9 CASES, 4 CASES, 8 CASES, AND 1 CASE, RESPECTIVELY, IN WHICH THE CASE WAS DIAGNOSED AS TOTAL BILE DUCT STONE AND THE CASE WAS SUSPECTED TO BE STONE BUT WAS DENIED BY EUS AND ERCP WAS AVOIDED. CONCLUSION: THERE ARE MANY CASES THAT BENEFIT FROM EUS EVEN IN REGIONAL HOSPITALS SUCH AS OUR HOSPITAL, AND THERE ARE MANY CASES THAT AFFECT THE TREATMENT POLICY. WE REPORT WITH A REVIEW OF THE LITERATURE. TYPE OF ADVERSE EVENTS / NUMBER OF PATIENTS. 1 CASE OF BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    924925 EVIS EUS ULTRASOUND GASTROINTESTINAL VIDEOSCOPE ULTRASOUND GASTROVIDEOSCOPE ODG OLYMPUS MEDICAL SYSTEMS CORP. GF-UE290

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other