BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS LUCERA BRONCHOVIDEOSCOPE

    MDR report key: 14111427 · Received April 14, 2022

    Report

    Report Number
    8010047-2022-06310
    Event Type
    Injury
    Date Received
    April 14, 2022
    Date of Event
    November 2, 2021
    Report Date
    June 22, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    EOQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION IS IN PROCESS. THE LITERATURE ARTICLE IS ATTACHED FOR ADDITIONAL INFORMATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH DEVICE EVALUATION RESULTS.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 8 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, THE 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. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    OLYMPUS WAS INFORMED OF THE FOLLOWING LITERATURE: "THE APPLICATION OF TRANSBRONCHIAL CRYOBIOPSY IN INTERSTITIAL LUNG DISEASE: A PROSPECTIVE, MULTICENTER, REAL-WORLD STUDY" BY XIAOBO CHEN, ET AL. THIS PROSPECTIVE, MULTICENTER, REAL-WORLD STUDY WAS CONDUCTED TO ANALYZE THE UNCLARIFIED DATA OF PATIENTS WITH INTERSTITIAL LUNG DISEASE (ILD) WHO UNDERWENT TRANSBRONCHIAL CRYOBIOPSY (TBCB) IN 20 HOSPITALS IN CHINA. A TOTAL OF 373 PATIENTS WERE ENROLLED IN AND ANALYZED FOR THE RESULTS OF THE PATHOLOGICAL AND MULTIDISCIPLINARY DISCUSSION (MDD) DIAGNOSIS AND COMPLICATIONS RELATED TO TBCB. IN CONCLUSION, THE STUDY SUGGESTED THAT THE APPLICATION OF TBCB IN ILD IS GENERALLY SAFE, AND ITS DIAGNOSTIC EFFICIENCY IS ACCEPTABLE. A 1.9-MM CRYOPROBE WAS USED TO COLLECT FIVE SAMPLES WOULD ACHIEVE A BETTER POSITIVE DIAGNOSTIC RATE FOR TBCB IN ILD WITHOUT A SIGNIFICANT INCREASE IN COMPLICATION RISK. THE PHYSICIANS USED BOTH BF-260 OR IT260 IN THE PROCEDURES. THE AUTHORS DID NOT SPECIFY WHICH ENDOSCOPE WAS USED ON THE SPECIFIC PATIENTS AND THEREFORE, THE FOLLOWING ADVERSE EVENTS WILL BE REPORTED. MODERATE BLEEDING WHICH WAS STOPPED BY WITH LOCAL INJECTION OF FROZEN SALINE, EPINEPHRINE, THE BALLOON OCCLUSION, OR INTRAVENOUS HEMOSTATIC DRUGS, (N=215). PNEUMOTHORAX: 17 PATIENTS REQUIRED CLOSED CHEST DRAINAGE, WHILE THE OTHER 2 WERE TREATED CONSERVATIVELY. ALL PNEUMOTHORAX PATIENTS RECOVERED WITHIN A WEEK - (N=19). THIS ARTICLE INCLUDES 10 REPORTS: (B)(6) FOR BF-260, SN (B)(4). (B)(6) FOR BF-1T260, SN (B)(4). THIS IS REPORT 10 OF 10.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146693 EVIS LUCERA BRONCHOVIDEOSCOPE BRONCHOVIDEOSCOPE EOQ OLYMPUS MEDICAL SYSTEMS CORP. BF-1T260

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| O