BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS LUCERA ELITE GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 19453412 · Received June 3, 2024

    Report

    Report Number
    9610595-2024-11123
    Event Type
    Injury
    Date Received
    June 3, 2024
    Date of Event
    April 15, 2024
    Report Date
    June 10, 2024
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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, A 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.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED. ATTEMPTS WERE PERFORMED TO OBTAIN ADDITIONAL INFORMATION, BUT NO RESPONSE WAS RECEIVED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE CORP. (OMSC) RECEIVED A LITERATURE TITLED "CASE REPORT ESOPHAGEAL SUBMUCOSAL HEMATOMA DURING TRANSNASAL ENDOSCOPY:A RARE CASE REPORT." LITERATURE SUMMARY ESOPHAGEAL SUBMUCOSAL HEMATOMA IS A RARE, OFTEN INCIDENTAL COMPLICATION OF THERAPEUTIC ENDOSCOPIC PROCEDURES MARKED BY DISRUPTED BLOOD VESSELS BENEATH THE ESOPHAGEAL MUCOSA, FORMING A HEMATOMA. WE REPORT THE UNIQUE CASE OF A SEVERELY THIN AND ALCOHOLIC 38-YEAR-OLD WOMAN WITH A HISTORY OF REFLUX ESOPHAGITIS WHO DEVELOPED AN ESOPHAGEAL SUBMUCOSAL HEMATOMA DURING AN UNSEDATED TRANSNASAL ENDOSCOPY FOR HEALTH CHECK-UP. DURING THE PROCEDURE, THE PATIENT EXPERIENCED STRONG VOMITING REFLEXES AND VOMITED BLOOD, LEADING TO THE INITIAL SUSPICION OF EITHER MALLORY-WEISS SYNDROME OR EPISTAXIS. HOWEVER, SUBSEQUENT SEDATED ENDOSCOPY REVEALED AN ESOPHAGEAL SUBMUCOSAL TUMOR-LIKE LESION AND A MUCOSAL LACERATION WITH BLOOD CLOTS, PROMPTING A DUAL DIAGNOSIS OF ESOPHAGEAL SUBMUCOSAL HEMATOMA AND MALLORY-WEISS SYNDROME. THE BLEEDING WAS NOT SEVERE ENOUGH TO REQUIRE HEMOSTATIC INTERVENTION. THE PATIENT OPTED FOR CONSERVATIVE TREATMENT WITH VONOPRAZAN, WHICH RESULTED IN THE IMPROVEMENT AND HEALING OF THE HEMATOMA WITHIN 28 DAYS. THIS IS THE FIRST REPORT OF AN ESOPHAGEAL SUBMUCOSAL HEMATOMA DURING TRANSNASAL ENDOSCOPY AND EMPHASIZES THE IMPORTANCE OF INCLUDING AN ESOPHAGEAL SUBMUCOSAL HEMATOMA AND MALLORY-WEISS SYNDROME IN THE DIFFERENTIAL DIAGNOSIS OF HEMATEMESIS ENCOUNTERED IN SIMILAR SCENARIOS. FACTORS SUCH AS SEVERE THINNESS, DAILY ALCOHOL CONSUMPTION, AND REFLUX ESOPHAGITIS MAY HAVE POSSIBLY CONTRIBUTED TO THE DEVELOPMENT OF THE ESOPHAGEAL SUBMUCOSAL HEMATOMA IN THIS PATIENT. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS EVENT1: MUCOSAL LACERATION CAUSING THE HEMATOMA TO BLEED (1 PATIENTS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    865315 EVIS LUCERA ELITE GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS AIZU OLYMPUS CO., LTD. GIF-XP290N

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Female Required Intervention