BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS EXERA III BRONCHOFIBERVIDEOSCOPE

    MDR report key: 20705596 · Received November 18, 2024

    Report

    Report Number
    9610595-2024-23540
    Event Type
    Injury
    Date Received
    November 18, 2024
    Date of Event
    June 12, 2024
    Report Date
    January 24, 2025
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    EOQ
    UDI-DI
    04953170395581
    PMA / PMN Number
    K172726
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE LITERATURE MENTIONED OLYMPUS BF-MP190 WAS USED, BUT MODEL- BF-MP190F WAS USED A REPRESENTATIVE DEVICE. THIS REPORT HAS BEEN SUBMITTED BY THE IMPORTER UNDER THIS MDR REPORT NUMBER 2429304-2024-0000465 THIS REPORT IS RELATED TO THE FOLLOWING LINKED PATIENT IDENTIFIER: (B)(6). ATTEMPTS WERE PERFORMED TO OBTAIN ADDITIONAL INFORMATION, BUT NO RESPONSE WAS RECEIVED. THE EVALUATION OF THE EVENT IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. ADDITIONALLY, TO PROVIDE A CORRECTION TO FIELD B3, AND TO PROVIDE ADDITIONAL INFORMATION RECEIVED FROM THE AUTHOR B5. THE DEVICE HISTORY RECORD WAS UNABLE TO BE REVIEWED FOR THIS DEVICE SINCE THE SERIAL AND/OR LOT NUMBER WAS NOT PROVIDED. HOWEVER, OLYMPUS ONLY RELEASES PRODUCTS TO MARKET THAT MEET ALL MANUFACTURING SPECIFICATIONS AND FINAL PRODUCT RELEASE CRITERIA. BASED ON THE RESULTS OF THE INVESTIGATION, THE REPORTED EVENT WAS LIKELY AN ACCIDENT, OR A COMPLICATION ASSOCIATED WITH A SURGICAL PROCEDURE WHILE USING THE SUBJECT DEVICE. THERE WAS NO COMPLAINT REPORTED ON THE SUBJECT DEVICE AND NO EVIDENCE OF AN OLYMPUS DEVICE MALFUNCTION. THEREFORE, THE ROOT CAUSE CANNOT BE DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED "ULTRATHIN BRONCHOSCOPY WITHOUT VIRTUAL NAVIGATION FOR DIAGNOSIS OF PERIPHERAL LUNG LESIONS". LITERATURE SUMMARY: BACKGROUND: THE INCREASING INCIDENCE OF ENCOUNTERING LUNG NODULES NECESSITATES AN ONGOING SEARCH FOR IMPROVED DIAGNOSTIC PROCEDURES. VARIOUS BRONCHOSCOPIC TECHNOLOGIES HAVE BEEN INTRODUCED OR ARE IN DEVELOPMENT, BUT FURTHER STUDIES ARE NEEDED TO DEFINE A METHOD THAT FITS BEST IN CLINICAL PRACTICE AND HEALTH CARE SYSTEMS. RESEARCH QUESTION HOW DO BASIC BRONCHOSCOPIC TOOLS INCLUDING A COMBINATION OF THIN (OUTER DIAMETER 4.2 MM) AND ULTRATHIN BRONCHOSCOPES (OUTER DIAMETER 3.0 MM), RADIAL ENDOBRONCHIAL ULTRASOUND (REBUS) AND FLUOROSCOPY PERFORM IN PERIPHERAL PULMONARY LESION DIAGNOSIS? STUDY DESIGN AND METHODS: THIS IS A RETROSPECTIVE REVIEW OF THE PERFORMANCE OF PERIPHERAL BRONCHOSCOPY USING THIN AND ULTRATHIN BRONCHOSCOPY WITH REBUS AND 2D FLUOROSCOPY WITHOUT A NAVIGATIONAL SYSTEM FOR EVALUATING PERIPHERAL LUNG LESIONS IN A SINGLE ACADEMIC MEDICAL CENTER FROM 11/2015 TO 1/2021. WE USED A STRICT DEFINITION FOR DIAGNOSTIC YIELD AND ASSESSED THE IMPACT OF DIFFERENT VARIABLES ON DIAGNOSTIC YIELD, SPECIFICALLY AFTER EMPLOYMENT OF THE ULTRATHIN BRONCHOSCOPE. LOGISTIC REGRESSION MODELS WERE EMPLOYED TO ASSESS THE INDEPENDENT ASSOCIATIONS OF THE MOST IMPACTFUL VARIABLES. RESULTS: A TOTAL OF 322 PATIENTS WERE INCLUDED IN THIS STUDY. THE MEDIAN OF THE LONG AXIS DIAMETER WAS 2.2 CM AND THE MEDIAN DISTANCE OF THE CENTER OF THE LESION FROM THE VISCERAL PLEURAL SURFACE WAS 1.9 CM. OVERALL DIAGNOSTIC YIELD WAS 81.3% AFTER EMPLOYMENT OF THE ULTRATHIN BRONCHOSCOPE, WITH MORE DETECTION OF CONCENTRIC REBUS VIEWS (93% VS. 78%, P < 0.001). SENSITIVITY FOR DETECTING MALIGNANCY ALSO INCREASED FROM 60.5% TO 74.7% (P = 0.033) AFTER INCORPORATING THE ULTRATHIN SCOPE INTO PRACTICE, WHILE BRONCHUS SIGN AND PERIPHERAL LOCATION OF THE LESION WERE NOT FOUND TO AFFECT DIAGNOSTIC YIELD. CONCENTRIC REBUS VIEW, SOLID APPEARANCE, UPPER/MIDDLE LOBE LOCATION AND LARGER SIZE OF THE NODULES WERE FOUND TO BE INDEPENDENT PREDICTORS OF SUCCESSFUL ACHIEVEMENT OF DIAGNOSIS AT BRONCHOSCOPY. INTERPRETATION: THIS STUDY DEMONSTRATES A HIGH DIAGNOSTIC YIELD OF BIOPSY OF LUNG LESIONS ACHIEVED BY UTILIZATION OF THIN AND ULTRATHIN BRONCHOSCOPES. DIRECT VISUALIZATION OF SMALL PERIPHERAL AIRWAYS WITH SIMULTANEOUS REBUS CONFIRMATION. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: EVENT 1- PNEUMOTHORAX (3 PATIENTS). EVENT 2- AIRWAY BLEEDING (5 PATIENTS).

    Description of Event or Problem · 0

    THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED FROM THE AUTHOR: AN OLYMPUS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE ADVERSE EVENT DESCRIBED IN THE ARTICLE. ALSO, IT WAS CONFIRMED THAT AN OLYMPUS DEVICE MALFUNCTION DID NOT OCCUR. ADDITIONALLY, THE AUTHOR NOTED THAT ULTRATHIN SCOPE INCREASED THE DIAGNOSTIC YIELD IN ADDITION TO THE THIN SCOPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2590497 EVIS EXERA III BRONCHOFIBERVIDEOSCOPE BRONCHOFIBERVIDEOSCOPE EOQ AIZU OLYMPUS CO., LTD. BF-MP190F 04953170395581

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R BF-P190, BRONCHOVIDEOSCOPE, SN-UNK.| DISPOSABLE BIOPSY FORCEPS. FB-231D, SN-UNK,| NA-1C-1, ASPIRATION NEEDLE, SN-UNK.| NA-403D-2021 SINGLE USE ASPIRATION NEEDLE, SN-UNK.| SINGE USE BIOPSY FORCEPS, FB-433D, SN-UNK.| UM-S20-17S, ULTRASONIC PROBE, SN-UNK,