BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS LUCERA ULTRASONIC BRONCHOFIBERVIDEOSCOPE

    MDR report key: 22048643 · Received May 19, 2025

    Report

    Report Number
    3002808148-2025-08203
    Event Type
    Injury
    Date Received
    May 19, 2025
    Date of Event
    December 28, 2024
    Report Date
    June 3, 2025
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    PSV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE APPROVED FINAL INVESTIGATION. UPDATED FIELDS: D8, H2, H6. BASED ON THE RESULTS OF THE INVESTIGATION, AND SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION, THE DEFINITIVE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    E1 INITIAL REPORTER ESTABLISHMENT NAME: (B)(6). THE LITERATURE DESCRIBED "BF-260" AND "UC-260-FW", SO OLYMPUS SELECTED ¿BF-UC260FW" AS THE REPRESENTATIVE MODEL FOR THIS REPORT. THIS REPORT IS RELATED TO THE FOLLOWING LINKED PATIENT IDENTIFIER: (B)(6). THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED.

    Description of Event or Problem · 0

    OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "THE IMPACT OF ANESTHESIA METHODS AND RAPID ON-SITE EVALUATION ON THE DIAGNOSIS OF LUNG CANCER USING ENDOBRONCHIAL ULTRASOUND-GUIDED TRANSBRONCHIAL NEEDLE ASPIRATION: A RETROSPECTIVE STUDY." BACKGROUND: ENDOBRONCHIAL ULTRASOUND-GUIDED TRANSBRONCHIAL NEEDLE ASPIRATION (EBUS-TBNA) IS A CRITICAL METHOD FOR DIAGNOSING LUNG CANCER. WHILE EBUS-TBNA IS COMMONLY PERFORMED UNDER CONSCIOUS SEDATION, THE POTENTIAL BENEFITS OF CONDUCTING THE PROCEDURE UNDER GENERAL ANESTHESIA AND INCORPORATING RAPID ON-SITE EVALUATION (ROSE) TO ENHANCE DIAGNOSTIC YIELD REMAIN UNCERTAIN. THIS STUDY AIMS TO INVESTIGATE THE IMPACT OF ANESTHESIA METHODS AND ROSE ON THE DIAGNOSTIC EFFICACY OF EBUS-TBNA FOR LUNG CANCER. METHODS: THIS STUDY COLLECTED DATA FROM PATIENTS WHO UNDERWENT EBUS-TBNA FOR SUSPECTED LUNG CANCER IN THE DEPARTMENT OF RESPIRATORY AND CRITICAL CARE MEDICINE AT THE AFFILIATED HOSPITAL OF SOUTHWEST MEDICAL UNIVERSITY FROM AUGUST 2018 TO DECEMBER 2023. PATIENTS WERE CATEGORIZED INTO THREE GROUPS BASED ON THE ANESTHESIA METHOD USED AND WHETHER ROSE WAS PERFORMED: THE NON-GENERAL ANESTHESIA GROUP (NGA GROUP), THE GENERAL ANESTHESIA GROUP (GA GROUP), AND THE GENERAL ANESTHESIA WITH ROSE GROUP (RGA GROUP). THE STUDY ANALYZED BASELINE CHARACTERISTICS, PUNCTURE DETAILS, DIAGNOSTIC OUTCOMES, AND COMPLICATIONS ACROSS THE GROUPS. RESULTS: THE NUMBER OF PUNCTURE NEEDLES USED IN THE RGA GROUP WAS SIGNIFICANTLY LOWER THAN IN THE OTHER TWO GROUPS (P<0.001). MOST PATIENTS RECEIVED A DEFINITIVE DIAGNOSIS, WITH MALIGNANT TUMOR DIAGNOSTIC RATES OF 80.95%, 85.71%, AND 93.44% IN THE NGA, GA, AND RGA GROUPS, RESPECTIVELY (P=0.12). THE OVERALL DISEASE DIAGNOSTIC RATES WERE 76.06%, 79.22%, AND 86.11%, RESPECTIVELY (P=0.30). NO SEVERE COMPLICATIONS OCCURRED IN ANY OF THE GROUPS. THE PROPORTION OF PATIENTS WILLING TO UNDERGO REPEAT EBUS-TBNA WAS SIGNIFICANTLY LOWER IN THE NGA GROUP COMPARED TO THE OTHER TWO GROUPS (P=0.002). A TOTAL OF 10 PATIENTS ACROSS THE THREE GROUPS EXPERIENCED SIGNIFICANT BLEEDING THAT REQUIRED ADDITIONAL PHARMACOLOGICAL INTERVENTION. ONE PATIENT EXPERIENCED BOTH HYPOXEMIA AND BLEEDING SIMULTANEOUSLY. BLEEDING IN ALL CASES WAS SUCCESSFULLY CONTROLLED FOLLOWING TREATMENT, NO PATIENT REQUIRED SURGICAL OR INTERVENTIONAL PROCEDURES. CONCLUSIONS: COMPARED TO LOCAL ANESTHESIA COMBINED WITH INTRAVENOUS ANALGESIA AND SEDATION OR GENERAL ANESTHESIA ALONE, GENERAL ANESTHESIA COMBINED WITH ROSE REDUCES THE NUMBER OF PUNCTURE NEEDLES REQUIRED DURING EBUS-TBNA BUT DOES NOT FURTHER IMPROVE DIAGNOSTIC EFFICACY. KEYWORDS: ENDOBRONCHIAL ULTRASOUND-GUIDED TRANSBRONCHIAL NEEDLE ASPIRATION (EBUS-TBNA); GENERAL ANESTHESIA (GA); RAPID ON-SITE EVALUATION (ROSE) . TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: BLEEDING (10 PATIENTS), HYPOXEMIA ( 2 PATIENTS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2050757 EVIS LUCERA ULTRASONIC BRONCHOFIBERVIDEOSCOPE ULTRASONIC BRONCHOFIBERVIDEOSCOPE PSV SHIRAKAWA OLYMPUS CO., LTD. BF-UC260FW

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention PUNCTURE NEEDLE (NA-201SX-4021).