BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 10043819 · Received May 11, 2020

    Report

    Report Number
    8010047-2020-02604
    Event Type
    Injury
    Date Received
    May 11, 2020
    Report Date
    October 22, 2020
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDS
    UDI-DI
    04953170343360
    PMA / PMN Number
    K112680
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE THE LEGAL MANUFACTURER¿S INVESTIGATION SUMMARY REGARDING THIS REPORT. THE LEGAL MANUFACTURER FURTHER REVIEWED THE LITERATURE AND SINCE THERE WERE NO REPORTED DEFECTS OR MALFUNCTION ON THE OLYMPUS¿ DEVICES ALLEGED, IT IS PRESUMED THAT THE REPORTED ADVERSE EVENTS WERE NOT RELATED TO PRODUCT DEFECTS/MALFUNCTIONS. THE CONCLUSIVE CAUSE OF THE PATIENT¿S EXPERIENCE CANNOT BE DETERMINED. CROSS REFERENCE RELATED COMPLAINTS 2951238-2020-00440, 2951238-2020-00438, 2951238-2020-00437.

    Additional Manufacturer Narrative · 1

    AS NO SERIAL NUMBERS WERE PROVIDED FOR THE SCOPES USED IN THE STUDY OLYMPUS IS UNABLE TO DETERMINE IF THE DEVICES WERE RETURNED FOR EVALUATION OR PERFORM A DEVICE HISTORY RECORD REVIEW. PLEASE REFERENCE IMPORTER MEDWATCH REPORT (B)(4). PODBOY, A., KOLAHI, S., FRIEDLAND, S. & LOUIE, C. (2020). ENDOSCOPIC SUBMUCOSAL DISSECTION IS ASSOCIATED WITH LESS PATHOLOGIC UNCERTAINTY THAN ENDOSCOPIC MUCOSAL RESECTION IN DIAGNOSING AND STAGING BARRETT¿S-RELATED NEOPLASIA. DIGESTIVE ENDOSCOPY, 32, 346-354. HTTPS://DOI.ORG/10.1111/DEN.13487.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A JOURNAL ARTICLE TITLED "ENDOSCOPIC SUBMUCOSAL DISSECTION IS ASSOCIATED WITH LESS PATHOLOGIC UNCERTAINTY THAN ENDOSCOPIC MUCOSAL RESECTION IN DIAGNOSING AND STAGING BARRETT¿S-RELATED NEOPLASIA." THE DOCUMENTED STUDY REVIEWED THE DIFFERENCE IN THE REMOVAL OF ESOPHAGEAL LESIONS VIA ENDOSCOPIC MUCOSAL RESECTION (EMR) AND ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD), PATHOLOGICAL SPECIMEN AND CLINICAL DECISION-MAKING AND THE SECONDARY EVALUATION OF THE EFFECT ON THE OUTCOME OF THE PATIENT. DURING THE STUDY, IT WAS REPORTED THAT DELAYED ESOPHAGEAL STRICTURES DEVELOPED IN FOUR OF THE PATIENTS, ONE IN THE EMR GROUP AND THREE IN THE ESD GROUP. IN ALL FOUR PATIENTS, THEY REQUIRED ENDOSCOPIC DILATATION. THERE WAS NO ADDITIONAL INFORMATION AVAILABLE. THIS COMPLAINT WILL CAPTURE 2 OF 3 PATIENTS IN THE ESD GROUP USING SCOPE MODEL NUMBER GIF-1TH190.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508772 EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS OLYMPUS MEDICAL SYSTEMS CORP. GIF-1TH190 04953170343360

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention