BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS EXERA ULTRASONIC BRONCHOFIBERVIDEOSCOPE

    MDR report key: 20311370 · Received September 26, 2024

    Report

    Report Number
    3002808148-2024-09272
    Event Type
    Injury
    Date Received
    September 26, 2024
    Date of Event
    April 30, 2024
    Report Date
    October 22, 2024
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    PSV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVALUATION OF THE EVENT IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS REPORT HAS BEEN SUBMITTED BY THE IMPORTER UNDER THIS MDR REPORT NUMBER 2429304-2024-0000421.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION, BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. 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. HOWEVER, 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 REVIEWED THE FOLLOWING LITERATURE TITLED "ENDOBRONCHIAL ULTRASOUND GUIDED TRANSBRONCHIAL NEEDLE ASPIRATION AND NEXT GENERATION SEQUENCING YIELDS." ABSTRACT: PURPOSE: THE USE OF ENDOBRONCHIAL ULTRASOUND (EBUS) IS STANDARD PRACTICE FOR LUNG CANCER DIAGNOSIS AND STAGING. NEXT GENERATION SEQUENCING (NGS) FOR DETECTION OF GENETIC ALTERATIONS IS RECOMMENDED IN ADVANCED, NON-SQUAMOUS, NON-SMALL CELL LUNG CANCER (NSCLC). EXISTING PROTOCOLS FOR NGS TESTING ARE MINIMAL AND REPORTED YIELDS VARY. THIS STUDY AIMED TO DETERMINE THE YIELD OF EBUS SAMPLES OBTAINED FOR NGS USING A SAMPLING PROTOCOL AT OUR INSTITUTION AND ASSESS PREDICTIVE FACTORS TO FORM COLLECTION PROTOCOLS. METHODS: WE REVIEWED EBUS BRONCHOSCOPIES FROM 2016 TO 2021 WITH NON-SQUAMOUS NSCLC DIAGNOSES. FOR TARGET LESIONS SUSPECTED TO BE MALIGNANT, THE SAMPLING PROTOCOL WAS: (A) TWO SLIDES FOR ON-SITE EVALUATION, (B) THREE TO FIVE FNE NEEDLE ASPIRATIONS RINSED INTO SALINE FOR IMMUNOHISTOCHEMICAL STAINING AND IN-HOUSE MOLECULAR MARKERS, AND (C) ADDITIONAL THREE TO FIVE RINSES FOR NGS. SUFFICIENCY FOR NGS PROCESSING WAS DETERMINED BY THE PATHOLOGY DEPARTMENT. RESULTS: TWO HUNDRED AND SEVENTY-EIGHT NON-SQUAMOUS NSCLC SAMPLES WERE OBTAINED BY EBUS (205 ADENOCARCINOMA; 73 NOT OTHERWISE SPECIFIED). EBUS WAS PERFORMED UNDER GENERAL ANESTHESIA IN 75.5% OF CASES. THE OVERALL SAMPLE ADEQUACY FOR NGS TESTING WAS 57.5%. HIGHER ADEQUACY RATES WERE OBSERVED WHEN PROTOCOL WAS ADHERED TO 66.0% VERSUS 37.2% (P<0.001). THERE WAS NO STATISTICALLY SIGNIFICANT DIFFERENCE BASED ON THE SIZE OF THE LESION OR LOCATION OF THE SAMPLE. THERE WERE 7 (2.5%) PROCEDURE RELATED COMPLICATIONS, WHICH INCLUDED HYPOXIA REQUIRING ADMISSION (0.4%, N=1), TRANSIENT BRONCHOSPASM OR DESATURATION (1.1%, N=3), OVERALL POOR TOLERANCE OF THE PROCEDURE (0.7%, N=2), AND OTHER COMPLICATIONS NOT SPECIFIED (0.4%, N=1). THERE WAS NO REPORTS OF PNEUMOTHORAX, HEMOPTYSIS, PNEUMONIA, HYPOTENSION, ARRHYTHMIA, OR DEATH. CONCLUSION: WHEN A PROTOCOL OF THREE TO FIVE DEDICATED NEEDLE RINSES FOR NGS WAS FOLLOWED, WE NEARLY DOUBLED OUR SAMPLE ADEQUACY RATE FOR NSG AS COMPARED TO STANDARD CARE. STUDIES ARE NEEDED TO DETERMINE THE IDEAL COLLECTION AND PROCESSING MODALITY TO PRESERVE TISSUE SAMPLES FOR GENETIC SEQUENCING. TYPE OF SERIOUS ADVERSE EVENTS/NUMBER OF PATIENTS HYPOXIA REQUIRING ADMISSION (1 PATIENT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2239873 EVIS EXERA ULTRASONIC BRONCHOFIBERVIDEOSCOPE ULTRASONIC BRONCHOFIBERVIDEOSCOPE PSV SHIRAKAWA OLYMPUS CO., LTD. BF-UC160F-OL8

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization UNKNOWN 21G NEEDLE