BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS LUCERA ULTRASOUND GASTROVIDEOSCOPE

    MDR report key: 8730345 · Received June 25, 2019

    Report

    Report Number
    8010047-2019-02283
    Event Type
    Injury
    Date Received
    June 25, 2019
    Report Date
    June 25, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    ODG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP (OMSC). OMSC COULD NOT REVIEW THE SERVICE AND MANUFACTURING RECORD BECAUSE THE SERIAL NUMBER WAS NOT PROVIDED FROM THE FACILITY. THE MALFUNCTION OF THE SUBJECT DEVICE CONCERNING THIS CASE HAS NOT BEEN REPORTED. THE EXACT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED ¿A CASE OF MEDIASTINAL ABSCESS CAUSED BY ENDOSCOPIC ULTRASOUND-GUIDED FINE NEEDLE ASPIRATION OF A MEDIASTINAL LESION¿. THE LITERATURE REPORTED THAT THE ENDOSCOPIC ULTRASOUND-GUIDED FINE NEEDLE ASPIRATION (EUS-FNA) HAS BEEN PERFORMED FOR DIAGNOSTIC PURPOSES IN PATIENTS WITH POSTERIOR MEDIASTINAL LESION. THE PROCEDURE WAS PERFORMED USING OLYMPUS ULTRASOUND GASTROVIDEOSCOPE MODEL GF-UCT260 AND BOSTON SCIENTIFIC ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE MODEL EXPECT. THE PROCEDURE WAS COMPLETED. IN ADDITION, THERE WERE NO SYMPTOMS SHOWING BLEEDING OR INFECTION AFTER THE PROCEDURE. THE PATIENT WAS DISCHARGED THE DAY AFTER THE PROCEDURE. SEVEN DAYS AFTER DISCHARGE, THE PATIENT COMPLAINED OF FEVER AND CHEST PAIN AND BECAME CONSCIOUSNESS DISORDER. THE PATIENT WAS DIAGNOSED AT THE USER FACILITY WITH PERICARDIAL FLUID RETENTION AND SEPTIC SHOCK DUE TO POSTERIOR MEDIASTINAL LESION AND EPICARDITIS. THE USER FACILITY PERFORMED AN URGENT DEBRIDEMENT SURGERY FOR THE PATIENT. IN ADDITION, THE USER FACILITY CONFIRMED THAT THE PATIENT WAS POSITIVE FOR VEILLONELLA PARVULA. THE USER FACILITY PERFORMED INTENSIVE CARE TO THE PATIENT FOR 4 DAYS AND THE PATIENT WAS DISCHARGED 28 DAYS AFTER THE SURGERY. BASED ON THE AVAILABLE INFORMATION, A DIRECT RELATIONSHIP BETWEEN THE OLYMPUS PRODUCT AND THE OBSERVED ADVERSE EVENTS COULD NOT BE DETERMINED. THIS IS 2ND OF 3 REPORTS (SEPTIC SHOCK).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523835 EVIS LUCERA ULTRASOUND GASTROVIDEOSCOPE ULTRASOUND GASTROVIDEOSCOPE ODG OLYMPUS MEDICAL SYSTEMS CORP. GF-UCT260

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention