BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 7016489 · Received November 9, 2017

    Report

    Report Number
    8010047-2017-01704
    Event Type
    Injury
    Date Received
    November 9, 2017
    Report Date
    March 3, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS SUBMITTED TO CORRECT "DEVICE PRODUCT CODE."

    Additional Manufacturer Narrative · 1

    THE MALFUNCTION OF THE SUBJECT DEVICE CONCERNING THIS CASE HAS NOT BEEN REPORTED. ALSO, SINCE THE SERIAL NUMBER OF THIS DEVICE IS UNKNOWN, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) COULD NOT CONFIRM THE MANUFACTURING HISTORY. BECAUSE THE USER FACILITY RECOGNIZED AS ACCIDENTAL SYMPTOM IN THE CONCLUSION OF THE REPORT, THIS CASE MAY NOT BE CAUSED DUE TO THE MALFUNCTION OF DEVICE. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    ON OCTOBER 12, 2017, OLYMPUS MEDICAL SYSTEMS CORP. RECEIVED A LITERATURE TITLED ¿EFFICACY AND SAFETY OF STENT INSERTION INTO COLON WITH MALIGNANT STRICTURE USING AN EXTREMELY THIN ENDOSCOPE¿ THAT WAS MADE IN PUBLIC IN 25TH JAPAN DIGESTIVE DISEASE WEEK ON OCTOBER 2017. COMPLICATIONS AFTER STENT PLACEMENT USING GIF-XP260N WERE REPORTED. THE FACILITY STUDIED THE CASES OF COLON STENT PLACEMENT PROSPECTIVELY, AND REPORTED EFFICACY AND SAFETY OF THE STENT PLACEMENT USING AN EXTREMELY THIN ENDOSCOPE. FROM AUGUST 2013 TO JANUARY 2017, 44 COLON STENT PLACEMENT CASES WERE PERFORMED AND COMPLICATIONS WITH PAIN AND FEVER WAS REPORTED. THE FACILITY ALSO REPORTED THAT IT IS POSSIBLE TO RELIABLY PLACE A GUIDEWIRE ON THE DISTAL SIDE FROM ANUS IN THE STRICTURE PART EVEN IF THE INTESTINAL CAVITY IS CURVED TIGHTLY BY USING AN EXTREMELY THIN ENDOSCOPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    793226 EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS OLYMPUS MEDICAL SYSTEMS CORP. GIF-XP260N

    Patients

    Seq Age Sex Outcome Treatment
    1 Other