BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS LUCERA BRONCHOVIDEOSCOPE

    MDR report key: 13498043 · Received February 9, 2022

    Report

    Report Number
    8010047-2022-02668
    Event Type
    Injury
    Date Received
    February 9, 2022
    Date of Event
    September 22, 2021
    Report Date
    May 20, 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 AND THE INVESTIGATION IS IN PROCESS. 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. NO DEVICE WAS SENT FOR EVALUATION, AND A SERIAL NUMBER WAS NOT PROVIDED. THE DHR WAS UNABLE TO BE REVIEWED FOR THIS DEVICE SINCE THE SERIAL NUMBER WAS NOT PROVIDED. HOWEVER, OLYMPUS ONLY RELEASES PRODUCTS TO MARKET THAT MEET ALL MANUFACTURING SPECIFICATIONS AND FINAL PRODUCT RELEASE CRITERIA. THE CASE IS NOT DUE TO DESIGN. COMPLAINT INFORMATION PROVIDED THE BASIS OF THIS INVESTIGATION. BASED ON THE RESULTS OF THE INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED. THIS WAS A STUDY REPORT THAT ¿AIMS TO EXPLORE THE DIAGNOSTIC EFFICIENCY AND SAFETY OF TBCB IN ILD IN A REAL WORLD SETTING¿. SINCE THE DEVICE WAS NOT SENT TO OLYMPUS, THE DEVICE WAS NOT ANALYZED. AS NO DEVICE WAS ALLEGED WITH DEFAULT WITH THIS REPORT, NO CAUSE WAS DEEMED APPLICABLE - ERGO, NO DEVICE PROBLEM WAS IDENTIFIED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION FROM THE AUTHOR: NEW INFORMATION ADDED.

    Additional Manufacturer Narrative · 0

    PLEASE SEE UPDATES IN B3, H4, H6, AND H10. THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE DEVICE HISTORY RECORD. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. THE DEVICE MET ALL SPECIFICATIONS AT THE TIME OF SHIPMENT. 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 (B)(6). 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 2 REPORTS: (B)(6) FOR BF-260; (B)(6) FOR BF-1T260. THIS IS REPORT 2 OF 2 FOR BF-1T260.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FROM THE AUTHOR: THE AUTHOR PROVIDED SERIAL NUMBERS FOR THE OLYMPUS DEVICES USED IN THE PROCEDURES. THE FOLLOWING ADDITIONAL COMPLAINTS HAVE BEEN OPENED AND ARE RELATED TO THIS REPORT: (B)(6) FOR BF-260, SN (B)(4), (B)(6) FOR BF-1T260, SN (B)(4), (B)(6): SN (B)(4), (B)(6): SN (B)(4), (B)(6): SN (B)(4), (B)(6): SN (B)(4), (B)(6): SN (B)(4), (B)(6): SN (B)(4), (B)(6): SN (B)(4), (B)(6): SN (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    945654 EVIS LUCERA BRONCHOVIDEOSCOPE BRONCHOVIDEOSCOPE EOQ OLYMPUS MEDICAL SYSTEMS CORP. BF-1T260

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| O