BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS EXERA III BRONCHOVIDEOSCOPE

    MDR report key: 9478544 · Received December 17, 2019

    Report

    Report Number
    8010047-2019-04366
    Event Type
    Injury
    Date Received
    December 17, 2019
    Report Date
    December 17, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    EOQ
    PMA / PMN Number
    K121959
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 ¿THE ACUTE EFFECTS OF BRONCHIAL THERMOPLASTY ON FEV1¿. THE FOLLOWING IS A SUMMARY OF THE LITERATURE: THIS STUDY EVALUATED THE ACUTE EFFECTS OF BRONCHIAL THERMOPLASTY (BT) IN FORCED EXPIRATORY VOLUME (FEV1) COUPLED WITH ALAIR BRONCHIAL THERMOPLASTY SYSTEM IN PATIENTS. PROSPECTIVE, OBSERVATIONAL STUDY. THE LITERATURE STUDY PERIOD WAS FROM APRIL 2016 TO JULY 2017. THE PROCEDURE WAS PERFORMED ON 20 PATIENTS. THE DETERIORATION IN LUNG FUNCTION AFTER BT IS TRANSIENT AND WELL-TOLERATED, BUT IS GREATEST AFTER UPPER LOBE TREATMENT, AND SIGNIFICANTLY RELATED TO THE NUMBER OF RADIOFREQUENCY ACTIVATIONS APPLIED. THE DETERIORATION IN LUNG FUNCTION AFTER BT IS TRANSIENT AND WELL-TOLERATED, BUT IS GREATEST AFTER UPPER LOBE TREATMENT, AND IS SIGNIFICANTLY RELATED TO THE NUMBER OF RADIOFREQUENCY ACTIVATIONS APPLIED. OLYMPUS BRONCHOVIDEOSCOPE MODEL BF-Q190 WAS USED FOR THE PROCEDURES. AMONG THE TARGETED PROCEDURES, 1 CASE WAS REPORTED FOR RIGHT UPPER LOBE PNEUMONIA IN THE PROCEDURE. THE USER FACILITY STATES THAT A PATIENT MADE A COMPLETE RECOVERY AND WAS DISCHARGED ON THE FOURTH DAY AND THERE WERE NO OTHER COMPLICATIONS. BASED ON THE AVAILABLE INFORMATION, A DIRECT RELATIONSHIP BETWEEN THE OLYMPUS PRODUCT AND THE OBSERVED ADVERSE EVENTS COULD NOT BE DETERMINED. THEREFORE, OMSC WILL SUBMIT 1 MEDICAL DEVICE REPORTS DEPENDING ON THE NUMBER OF ADVERSE EVENTS. THIS REPORT IS A REPORT OF RIGHT UPPER LOBE PNEUMONIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1274853 EVIS EXERA III BRONCHOVIDEOSCOPE BRONCHOVIDEOSCOPE EOQ OLYMPUS MEDICAL SYSTEMS CORP. BF-Q190

    Patients

    Seq Age Sex Outcome Treatment
    1 Other