BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS LUCERA BRONCHOVIDEOSCOPE

    MDR report key: 10526575 · Received September 14, 2020

    Report

    Report Number
    8010047-2020-06464
    Event Type
    Injury
    Date Received
    September 14, 2020
    Report Date
    September 14, 2020
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    EOQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP (OMSC). THE MALFUNCTION OF THE SUBJECT DEVICE CONCERNING THIS CASE HAS NOT BEEN REPORTED. THE EXACT CAUSE COULD NOT BE DETERMINED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED "BRONCHOSCOPIC ARGON PLASMA COAGULATION, HIGH-FREQUENCY RADIO-WAVE ELECTROSURGERY, AND CRYOTHERAPY FOR TRACHEAL STENOSIS". THE LITERATURE REPORTED THE RESULT OF 80 PATIENTS WITH TRACHEAL STENOSIS OF THE BRONCHOSCOPIC ARGON PLASMA COAGULATION OR/AND HIGH-FREQUENCY RADIO-WAVE ELECTROSURGERY USING OLYMPUS BRONCHOVIDEOSCOPE FROM JANUARY 2016 TO JUNE 2019. IN THE SUBJECT CASES, INFECTION OCCURRED IN 2 PATIENTS. THEREFORE, OMSC WILL SUBMIT TWO MEDICAL DEVICE REPORTS (MDR) DEPENDING ON THE EVENT. THIS REPORT IS 2 OF 2 REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    991718 EVIS LUCERA BRONCHOVIDEOSCOPE BRONCHOVIDEOSCOPE EOQ OLYMPUS MEDICAL SYSTEMS CORP. BF-1T260

    Patients

    Seq Age Sex Outcome Treatment
    1 Other