BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRASONIC BRONCHOFIBERVIDEOSCOPE

    MDR report key: 17304788 · Received July 12, 2023

    Report

    Report Number
    3002808148-2023-06994
    Event Type
    Injury
    Date Received
    July 12, 2023
    Date of Event
    October 21, 2022
    Report Date
    July 12, 2023
    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

    THE SUSPECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE LITERATURE ARTICLE IS ATTACHED FOR ADDITIONAL INFORMATION HTTPS://DOI.ORG/10.1016/ S2213-2600(22)00392-7. AS THE LOT NUMBER/MANUFACTURING NUMBER OF THE DEVICE USED IS UNKNOWN AND WAS NOT PROVIDED, THE DEVICE HISTORY RECORD CANNOT BE INVESTIGATED. HOWEVER, OLYMPUS CONDUCTS INSPECTIONS AND ONLY SHIPS PRODUCTS THAT PASS THE INSPECTIONS. BASED ON THE INFORMATION AVAILABLE, IT IS NOT POSSIBLE TO IDENTIFY THE ROOT CAUSE OF THE REPORTED EVENT. HOWEVER, IT IS LIKELY THE REPORTED EVENT IS AN ACCIDENT, OR A COMPLICATION ASSOCIATED WITH A SURGICAL PROCEDURE USING THE SUBJECT DEVICE. THERE WAS NO COMPLAINT REPORTED ON THE SUBJECT DEVICE. THERE IS NO EVIDENCE OF AN OLYMPUS DEVICE MALFUNCTION. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE.

    Description of Event or Problem · 0

    OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "TRANSBRONCHIAL NEEDLE ASPIRATION COMBINED WITH CRYOBIOPSY IN THE DIAGNOSIS OF MEDIASTINAL DISEASES: A MULTICENTRE, OPEN-LABEL, RANDOMISED TRIAL.¿ THIS PROSPECTIVE STUDY AIMED TO EVALUATE THE EFFICACY AND SAFETY OF COMBINED APPLICATION OF ENDOBRONCHIAL ULTRASOUND-GUIDED TRANSBRONCHIAL NEEDLE ASPIRATION (EBUS-TBNA) AND MEDIASTINAL CRYOBIOPSY VERSUS EBUS-TBNA ALONE FOR THE DIAGNOSIS OF MEDIASTINAL DISEASES. A TOTAL OF 271 PATIENTS WERE RANDOMLY ASSIGNED TO RECEIVE EITHER EBUS-TBNA PLUS TRANSBRONCHIAL MEDIASTINAL CRYOBIOPSY (COMBINED GROUP; N=136) OR EBUS-TBNA ALONE (CONTROL GROUP; N=135; FIGURE). SEQUENTIAL APPLICATION OF EBUS-TBNA AND TRANS BRONCHIAL MEDIASTINAL CRYOBIOPSY LED TO A SIGNIFICANT INCREASE IN THE OVERALL DIAGNOSTIC YIELD COMPARED WITH EBUS-TBNA ALONE (126 [93%] OF 136 PARTICIPANTS IN THE COMBINED GROUP VS 109 [81%] OF 135 IN THE CONTROL GROUP. WHEREAS THE COMBINED BIOPSY WAS MORE SENSITIVE THAN EBUS-TBNA ALONE IN BENIGN DISEASES (45 [94%] OF 48 VS 28 [64%] OF 44, RR 1·47 [95% CI 1·17¿1·86]; P=0·0004. THE OVERALL DIAGNOSTIC YIELD OF 82% (110 OF 134 PARTICIPANTS) FOR EBUS-TBNA AND 91% (122 OF 134) FOR CRYOBIOPSY (RR 1·11 [95% CI 1·01¿1·22]; P=0·032). IN CONCLUSION, CRYOBIOPSY PROVED SAFE AND LED TO A SIGNIFICANT GAIN IN OVERALL DIAGNOSTIC YIELD COMPARED WITH EBUS-TBNA ALONE. TYPES OF ADVERSE EVENTS AND NUMBER OF PATIENTS INVOLVING THE ULTRASONIC BRONCHOFIBERVIDEOSCOPE ARE AS FOLLOWS: BLEEDING (GRADE 3) - 5 PATIENTS BLEEDING (GRADE 2) - 30 PATIENTS COUGHING - 31 PATIENTS DYSPNOEA - 6 PATIENTS HAEMOPTYSIS - 5 PATIENTS PNEUMOTHORAX - 6 PATIENTS PNEUMOMEDIASTINUM -1 PATIENT MINOR BLEEDING (GRADE 2) SUBSIDED WITHOUT THE NEED FOR INTERVENTION. THE INCIDENCE OF PNEUMOTHORAX AND PNEUMOMEDIASTINUM WERE DETECTED BY CHEST RADIOGRAPHY, ALTHOUGH NONE OF THESE REQUIRED DRAINAGE OR OTHER TREATMENT. NO SERIOUS ADVERSE EVENTS WERE REPORTED DURING THE PROCEDURE OR AT THE 4 WEEK FOLLOW UP. TYPES OF ADVERSE EVENTS AND NUMBER OF PATIENTS INVOLVING THE ELECTROSURGICAL KNIFE ARE AS FOLLOWS: BLEEDING (GRADE 2) - 16 PATIENTS BLEEDING (GRADE 3) ¿ 3 PATIENTS COUGHING - 19 PATIENTS DYSPNOEA - 2 PATIENTS HAEMOPTYSIS - 3 PATIENTS PNEUMOTHORAX - 6 PATIENTS PNEUMOMEDIASTINUM -1 PATIENT THIS LITERATURE ARTICLE REQUIRES 2 REPORTS. THE RELATED PATIENT IDENTIFIERS ARE AS FOLLOWS: C23277677 / KD-31C-1 C23277679 / BF-UC260F-OL8 THIS MEDWATCH REPORT IS FOR PATIENT IDENTIFIER C23277679. 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
    190356 ULTRASONIC BRONCHOFIBERVIDEOSCOPE ULTRASONIC BRONCHOFIBERVIDEOSCOPE PSV SHIRAKAWA OLYMPUS CO., LTD. BF-UC260F-OL8

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other NON-OLYMPUS NEEDLE-KNIFE (20402-401)