BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE

    MDR report key: 18042692 · Received October 31, 2023

    Report

    Report Number
    3002808148-2023-12064
    Event Type
    Injury
    Date Received
    October 31, 2023
    Date of Event
    June 27, 2023
    Report Date
    November 30, 2023
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    PSV
    UDI-DI
    04953170399831
    PMA / PMN Number
    K183525
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    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 EVENT 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. THIS SUPPLEMENTAL REPORT INCLUDES INFORMATION ADDED TO B5. 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 "SAFETY AND FEASIBILITY OF OESOPHAGEAL ULTRASOUND FOR THE WORK-UP OF THORACIC MALIGNANCY IN PATIENTS WITH RESPIRATORY IMPAIRMENT". LITERATURE SUMMARY: THIS PROSPECTIVE STUDY AIMED AT ASSESSING FEASIBILITY AND SAFETY OF ENDOBRONCHIAL ULTRASOUND-ENDOSCOPE VIA THE OESOPHAGUS (EUS-B-FNA) FROM CENTRALLY LOCATED TUMOURS SUSPECTED OF THORACIC MALIGNANCY IN PATIENTS WITH RESPIRATORY INSUFFICIENCY. (B)(4). THE DIAGNOSTIC YIELD WAS (B)(4) WITH A MALIGNANT DIAGNOSIS IN (B)(4) PATIENTS, WHO WERE REFERRED FOR CANCER THERAPY WITHOUT FURTHER INVASIVE PROCEDURES. IN CONCLUSION, EUS-B-FNA OF CENTRALLY LOCATED TUMOURS WAS FEASIBLE AND SAFE IN THIS COHORT OF PATIENTS WITH RESPIRATORY IMPAIRMENT, WHEN EXAMINED IN THE BRONCHOSCOPY SUITE. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: HYPOXEMIA (13). DECREASED SYSTOLIC BP (1). DECREASED RR AND SOMNOLENCE (1). TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS. DURING THE PROCEDURE, (B)(4) AES OCCURRED IN (B)(4) PATIENTS, PREDOMINANTLY HYPOXEMIC EVENTS. ALL THE ADVERSE EVENTS HAPPENED WITHIN THE FIRST 15 MIN OF THE PROCEDURES, AND ALL WERE MANAGED SATISFACTORILY BY THE ENDOSCOPY TEAM. (B)(4) CASES OF HYPOXEMIA WERE TREATED WITH INCREASED OXYGEN SUPPLY ALONE. TWO CASES OF HYPOXEMIA IN ONE PATIENT, SECONDARILY TO BREATH HOLDING TRIGGERED BY NAUSEA AND GAG REFLEX, WERE TREATED WITH OXYGEN SUPPLY AND CONTINUOUS BREATHING INSTRUCTIONS BY THE ENDOSCOPIST. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AS THE PATIENT DID NOT VOMIT OR ASPIRATE. ONE PATIENT WITH HYPOXEMIA AND DECREASED SYSTOLIC BP WAS TREATED WITH OXYGEN SUPPLY AND INTRAVENOUS FLUMAZENIL. ONE PATIENT WITH DECREASING RR DURING THE PROCEDURE AND POST-PROCEDURAL SOMNOLENCE WAS TREATED WITH INTRAVENOUS FLUMAZENIL ALONE. OF THE EIGHT PATIENTS WITH AES, THREE WERE HOSPITALIZED PRIOR TO, AND AFTER THE PROCEDURE. DURING THE 1-HOUR POST-PROCEDURE RECOVERY, THREE AES WERE OBSERVED IN 2 PATIENTS¿ALL WERE HYPOXEMIC EVENTS THAT WERE TREATED BY THE ENDOSCOPY TEAM. TWO PATIENTS (ONSET AFTER 30 MINS) WERE TREATED WITH INCREASED OXYGEN SUPPLY. ONE CASE (ONSET AFTER 30 MIN) WAS TREATED WITH OXYGEN SUPPLY AND INHALATION OF VAPORIZED SHORT-ACTING BRONCHODILATORS. ALL BUT ONE PATIENT HAD RETURNED TO PRE-PROCEDURE CONDITION 60 MIN AFTER ENDED EUS-B. A TOTAL OF FIVE EVENTS WERE IDENTIFIED (ONE PROLONGED NEED OF OXYGEN SUPPLY, ONE INFECTION, ONE INTENSIVE CARE UNIT (ICU) ADMISSION, TWO HOSPITALIZATIONS) HOWEVER ONLY THE FIRST TWO WERE CONSIDERED AS LIKELY PROCEDURE RELATED. LIKELY EUS-B-RELATED EVENTS WERE REPORTED TO BE PROLONGED OXYGEN TREATMENT: 1 IN-PATIENT TREATED WITH FLUMAZENIL NEEDING SUPPLEMENTARY OXYGEN FOR 3 HOURS AFTER ENDED EUS-B WITHOUT ANY IMPACT ON LENGTH OF HOSPITALIZATION OR OTHER CONSEQUENCES. INFECTION/PNEUMONIA: ONE IN-PATIENT EXPERIENCED FEVER AND INCREASED BLOOD C-REACTIVE PROTEIN (CRP) (78 MG/L) ON DAY 5 POST-PROCEDURE AND WAS TREATED WITH ORAL ANTIBIOTICS WITHOUT PROLONGING ADMISSION. THERE WAS NO RADIOLOGICAL OR MICROBIOLOGICAL CONFIRMATION OF INFECTION. UNLIKELY EUS-B-RELATED EVENTS WERE REPORTED -1 PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT A WEEK EARLIER DUE TO RAPIDLY PROGRESSIVE BREATHLESSNESS AND CLINICAL DETERIORATION WITHOUT PRE-EXISTING CARDIOPULMONARY DISEASE. SUPPLEMENTARY OXYGEN (3 L/MIN; NASAL CANNULA) WAS NEEDED TO KEEP SATURATION >90%, AND CLINICIANS CONSIDERED LYMPHOMA LIKELY, AND THAT EUS-B WAS THE ONLY TOLERATED PROCEDURE TO DIAGNOSE THE MASSIVE MEDIASTINAL MASSES. A FEW HOURS AFTER AN UNCOMPLICATED EUS-B PROCEDURE, PROGRESSIVE TUMOR PRESSURE SYMPTOMS (PARTIAL COMPRESSION OF AIRWAYS AND THE LEFT PULMONARY ARTERY) WERE TREATED IN THE ICU WITH NON-INVASIVE VENTILATION. HIGH-DOSE GLUCOCORTICOID AND CHEMOTHERAPY WERE CONSEQUENTLY COMMENCED RESULTING IN MARKED CLINICAL RESPONSE I.E., DISCHARGE FROM THE HOSPITAL AND CESSATION OF SUPPLEMENTAL OXYGEN THERAPY. HOSPITALIZATION: TWO OUT-PATIENT CASES WERE HOSPITALIZED WITHIN 30 DAYS DUE TO THEIR ADVANCED CANCER WITHOUT RELATION TO THE ENDOSCOPIC PROCEDURE. THIS LITERATURE ARTICLE REQUIRES 4 REPORTS. THE RELATED PATIENT IDENTIFIERS ARE AS FOLLOWS: 1. (B)(6) (BF-UC190F). 2. (B)(6) (BF-UC180F). 3. (B)(6) (NA-201SX-4021). 4. (B)(6) (NA-U403SX-4019). 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.

    Description of Event or Problem · 0

    THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED FROM THE AUTHOR: THERE WAS NO DEVICE MALFUNCTION. THE PATIENT EVENTS DESCRIBED IN THE ARTICLE ARE NOT RELATED TO AN OLYMPUS DEVICE, BUT RELATED TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2091462 EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE BRONCHOFIBERVIDEOSCOPE PSV SHIRAKAWA OLYMPUS CO., LTD. BF-UC190F 04953170399831

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R BRONCHOSCOPE, BF-UC180F, SERIAL# UNK.| SINGLE USE ASPIRATION NEEDLE, NA-201SX-4021, SN UNK.| SINGLE USE ASPIRATION NEEDLE,NA-U403SX-4019, SN UNK.