BEUDAMED
    FDA Adverse Event Death Summary report: N

    EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE

    MDR report key: 18013578 · Received October 26, 2023

    Report

    Report Number
    3002808148-2023-11875
    Event Type
    Death
    Date Received
    October 26, 2023
    Date of Event
    March 20, 2019
    Report Date
    December 4, 2023
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    PSV
    UDI-DI
    04953170356360
    PMA / PMN Number
    K070983
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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 RELATIONSHIP BETWEEN THE DEVICE AND THE ADVERSE EVENTS CANNOT BE CONFIRMED. THERE WAS NO COMPLAINT REPORTED ON THE SUBJECT DEVICE. THERE IS NO EVIDENCE OF AN OLYMPUS DEVICE MALFUNCTION. THEREFORE, THE ROOT CAUSE CANNOT BE DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    SINCE THE ARTICLE DESCRIBED "EBUS-TBNA", OLYMPUS SELECTED BF-UC180F AS A REPRESENTATIVE PRODUCT. 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.

    Description of Event or Problem · 0

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED "CYTOLOGY VERSUS HISTOLOGY IN THE PRIMARY DIAGNOSIS OF LYMPHOMA LOCATED IN THE MEDIASTINUM". BACKGROUND. ENDOBRONCHIAL ULTRASOUND¿GUIDED TRANSBRONCHIAL NEEDLE ASPIRATIONS (EBUS-TBNAS) ARE WELL ESTABLISHED FOR STAGING LUNG CANCER. A GROWING NUMBER OF PUBLICATIONS REPORT ON LYMPHOMA DIAGNOSIS VIA EBUS-TBNA¿ACQUIRED CYTOLOGY; HOWEVER CURRENT GUIDELINES RECOMMEND HISTOLOGIC DIAGNOSIS. RESEARCH ON THE VALUE OF EBUS-TBNA¿ACQUIRED CYTOLOGY VERSUS SURGICAL-ACQUIRED HISTOLOGY IN THE DIAGNOSIS OF LYMPHOMA IS LACKING. METHODS. WE CONDUCTED A RETROSPECTIVE REVIEW OF PATIENTS WITH MEDIASTINAL LYMPHOMA DIAGNOSED BETWEEN 2010 AND 2016. MEDIASTINAL LYMPHADENOPATHY WAS ACCESSIBLE THROUGH BOTH EBUS-TBNAS AND SURGICAL PROCEDURES. ALL DATA WERE EXTRACTED FROM OUR CLINIC¿S MEDICAL DATABASE AND ANALYZED. RESULTS. FIFTY-ONE PATIENTS NEWLY DIAGNOSED WITH LYMPHOMA IN THE MEDIASTINUM WERE IDENTIFIED (MEDIAN AGE, 43.5 YEARS; MEAN AGE, 48.6 ± 20.6 YEARS). A MINIMALLY INVASIVE PROCEDURE WAS PERFORMED AS A FIRST DIAGNOSTIC STEP IN 29 PATIENTS, WHEREAS SURGICAL BIOPSY WAS PERFORMED IN THE REMAINING 22. THE TIME TO FINAL DIAGNOSIS WAS SIGNIFICANTLY LONGER IF A MINIMALLY INVASIVE PROCEDURE WAS PERFORMED FIRST COMPARED WITH A SURGICAL PROCEDURE (MEAN, 44 DAYS [MEDIAN, 38 DAYS] VS 16 DAYS [MEDIAN, 8 DAYS]; P < 0.030). THE NUMBER OF PROCEDURES TO OBTAIN A FINAL DIAGNOSIS RANGED FROM ONE TO FIVE (MEDIAN, 2 PROCEDURES PER PATIENT) IN THE EBUS-TBNA GROUP. THIS WAS SIGNIFICANTLY HIGHER THAN THAT IN THE SURGICAL GROUP (MEDIAN, 1 PROCEDURE PER PATIENT; P < 0.00005). IN BOTH PATIENTS EBUS-TBNA WAS PERFORMED: IN 1 PATIENT IT WAS THE FIRST DIAGNOSTIC PROCEDURE, WHEREAS IN THE OTHER IT WAS A SECONDARY PROCEDURE AFTER AN INITIALLY UNSUCCESSFUL EBUS-TBNA. IN BOTH CASES THE COMPLICATION WAS RESPIRATORY INSUFFICIENCY, WITH BOTH PATIENTS TRANSFERRED TO THE INTENSIVE CARE UNIT. ONE PATIENT DIED IN THE INTENSIVE CARE UNIT. CONCLUSIONS. WE DEMONSTRATE THAT SURGICAL BIOPSIES ARE SAFE AND WELL TOLERATED FOR LYMPHOPROLIFERATIVE DISEASE DIAGNOSIS AND LEAD TO A FINAL DIAGNOSIS IN THE SHORTEST POSSIBLE TIME. UNNECESSARY PROCEDURES WERE SIGNIFICANTLY REDUCED IF A SURGICAL BIOPSY WAS PERFORMED AS THE FIRST STEP. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: RESPIRATORY INSUFFICIENCY (DEATH) - 1 PATIENT, RESPIRATORY INSUFFICIENCY - 1 PATIENT. THIS LITERATURE ARTICLE REQUIRES 2 REPORTS. THE RELATED PATIENT IDENTIFIERS ARE AS FOLLOWS: (B)(6): BF-UC180F (DEATH): (B)(6): BF-UC180F (RESPIRATORY INSUFFICIENCY). THIS MEDWATCH REPORT IS FOR PATIENT IDENTIFIER (B)(6). THERE IS NO REPORT OF ANY OLYMPUS DEVICE MALFUNCTION IN ANY PROCEDURE DESCRIBED IN THIS STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2141078 EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE ULTRASONIC BRONCHOFIBERVIDEOSCOPE PSV SHIRAKAWA OLYMPUS CO., LTD. BF-UC180F 04953170356360

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death| H