BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS LUCERA ELITE BRONCHOVIDEOSCOPE

    MDR report key: 17391695 · Received July 25, 2023

    Report

    Report Number
    9610595-2023-10570
    Event Type
    Injury
    Date Received
    July 25, 2023
    Date of Event
    February 22, 2023
    Report Date
    August 3, 2023
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    EOQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NO INFORMATION COULD BE PROVIDED. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ADDITIONAL INFORMATION IS RECEIVED.

    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 IS NO EVIDENCE OF AN OLYMPUS DEVICE MALFUNCTION. IN ADDITION, THE MALFUNCTION OF THE DEVICE HAS NOT BEEN REPORTED, AND FROM CLINICAL/MEDICAL EVALUATION AND RISK ASSESSMENT, IT IS POSSIBLE THAT THE REPORTED EVENT IS AN ACCIDENT, OR A COMPLICATION ASSOCIATED WITH A PROCEDURE USING THE SUBJECT DEVICE. 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 "FLEXIBLE BRONCHOSCOPY IN PEDIATRIC PATIENTS WITH DOWN SYNDROME: A CASE-CONTROL STUDY OF THE INDICATIONS, FINDINGS, AND COMPLICATIONS." LITERATURE SUMMARY: THIS RETROSPECTIVE CASE-CONTROL STUDY DESCRIBE THE INDICATIONS, FINDINGS, AND COMPLICATIONS OF FLEXIBLE BRONCHOSCOPY IN A LARGE COHORT OF PEDIATRIC DOWN SYNDROME (DS) PATIENTS COMPARED TO A MATCHED CONTROL GROUP OF CHILDREN WITH RESPIRATORY SYMPTOMS WITHOUT DS. A TOTAL OF 200 PATIENTS WERE INCLUDED, 50 PATIENTS IN DOWN SYNDROME GROUP AND 150 PATIENTS IN CONTROL GROUP. THE MEDIAN LENGTH OF HOSPITALIZATION WAS 24 DAYS FOR DS PATIENTS (RANGE 11-71) AND FOUR DAYS FOR CONTROLS (RANGE 2-9), P < 0.01. COMMON INDICATIONS AMONG THE DS GROUP INCLUDED OBSTRUCTIVE SLEEP APNEA-RELATED SYMPTOMS AND OXYGEN DEPENDENCE, COM PARED WITH THE CONTROL GROUP (38% VS. 8%, P < 0.01, AND 22% VS. 4%, P < 0.01, RESPECTIVELY). IN THE DS GROUP, SOFT PALATE INCOMPETENCE AND TRACHEAL BRONCHUS WERE MORE FREQUENT THAN IN THE CONTROL GROUP (12% VS. 3.3%, 8% VS. 0.7%, RESPECTIVELY, P = 0.025, P = 0.024), COMPLICATIONS WERE OBSERVED 2.36 TIMES MORE FREQUENTLY IN THE DS GROUP (22% VS. 9.3% IN CONTROLS, P = 0.028). IN CONCLUSION, DS PEDIATRIC PATIENTS PRESENT UNIQUE ENDOSCOPIC FINDINGS AND MIGHT SUFFER A HIGH RATE OF INTRA AND POST-BRONCHOSCOPY COMPLICATIONS. COMPLICATIONS INCLUDED DESATURATION (REQUIRING TERMINATION OF THE PROCEDURE), INTUBATION, BLEEDING, FEVER- DEFINED AS A TEMPERATURE > 38°C OBSERVED WITHIN 24 H AFTER THE PROCEDURE, AND HOSPITALIZATION IN A PEDIATRIC WARD OR PICU WITHIN 72 H AFTER THE PROCEDURE. COMPLICATIONS WERE OBSERVED 2.36 TIMES MORE FREQUENTLY IN THE DS GROUP (22% VS. 9.3% IN CONTROLS, P = 0.028). FOUR PATIENTS (8%) OF THE DS GROUP AND NONE OF THE CONTROL PATIENTS WERE ADMITTED TO PICU FOLLOWING THE PROCEDURE DUE TO HEMODYNAMIC OR RESPIRATORY INSTABILITY (P = 0.004). NINE DS PATIENTS (18%) AND 12 CONTROL PATIENTS (8%) HAD DESATURATION, REQUIRING TERMINATION OF THE PROCEDURE AND VENTILATION USING A BAG VALVE MASK UNTIL RESOLUTION (P = 0.057). TWO DS PATIENTS AND NONE OF THE CONTROL PATIENTS WERE INTUBATED FOLLOWING THE PROCEDURE. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENT: DOWN SYNDROME (DS) GROUP. DESATURATION - 9 PATIENTS. HOSPITALIZATION - 2 PATIENTS. FEVER - 4 PATIENTS. INTUBATION - 2 PATIENTS. PICU ADMISSION - 4 PATIENTS. CONTROL GROUP: DESATURATION - 12 PATIENTS. HOSPITALIZATION - 2 PATIENTS. FEVER - 12 PATIENTS. BLEEDING - 1 PATIENT. 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
    1635179 EVIS LUCERA ELITE BRONCHOVIDEOSCOPE BRONCHOVIDEOSCOPE EOQ AIZU OLYMPUS CO., LTD. BF-XP290

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R