BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE

    MDR report key: 12316945 · Received August 12, 2021

    Report

    Report Number
    8010047-2021-10198
    Event Type
    Malfunction
    Date Received
    August 12, 2021
    Date of Event
    July 21, 2021
    Report Date
    September 27, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    PSV
    PMA / PMN Number
    K183525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. OLYMPUS SERVICE RECEIVED THE FOREIGN MATERIAL, AND AS A RESULT OF ANALYSIS, CONFIRMED THE FOLLOWING. -THE FOREIGN MATERIAL WAS VERY SIMILAR TO THE CARBON POWDER USED TO LUBRICATE THE BENDING SECTION OF THE ENDOSCOPE. BASED ON THE HOLES IN THE BIOPSY CHANNEL OF THE BENDING SECTION OF THE DEVICE, IT WAS CONCLUDED THAT THE FOREIGN MATERIAL WAS CARBON POWDER. IT IS PROBABLE THAT THE FOREIGN MATERIAL THAT CAME OUT OF THE DEVICE WAS A POWDER THAT WAS APPLIED DURING THE MANUFACTURING PROCESS OF THE DEVICE. OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) SURMISED THAT THE COATING POWDER ENTERED THE DEVICE THROUGH A HOLE IN THE INSTRUMENT CHANNEL AND WAS DETECTED AS THE FOREIGN MATERIAL. OMSC CONCLUDED THAT THE REPORTED EVENT WAS MOST LIKELY CAUSED BY USER'S HANDLING, AS PERFORATION OF THE INSTRUMENT CHANNEL CAN BE PREVENTED BY OBSERVING THE PRECAUTIONS CONTAINED IN THE INSTRUCTION MANUAL. THE INSTRUCTION MANUAL CONTAINS WARNINGS ABOUT THE USE OF ENDOTHERAPY ACCESSORIES. OMSC DETERMINED THAT COMPLIANCE WITH THIS WILL PREVENT THE OCCURRENCE OF THE REPORTED EVENT. DEVICE HISTORY RECORD (DHR) REVIEW INDICATES THAT THE PRODUCT WAS MANUFACTURED AND TESTED IN ACCORDANCE WITH ALL APPLICABLE PROCEDURES AND MET ALL FINAL PRODUCT RELEASE CRITERIA. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED AT OLYMPUS (B)(4) AS A RESULT OF THE EVALUATION, THE FOLLOWING WAS CONFIRMED. THERE WAS A LEAKAGE FROM THE BIOPSY CHANNEL. THE DISTAL END NEEDS TO BE REPLACED. THERE WAS NO EVIDENCE OF LIQUID INTRUSION INTO THE ENDOSCOPE CONNECTOR, AND THE CCD FUNCTION WAS GOOD. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED BY THE USER THAT DURING THE ENDOBRONCHIAL ULTRASONOGRAPHY, FOREIGN MATERIAL CAME OUT OF THE DEVICE. THE FOREIGN MATERIAL WAS STORED FOR INVESTIGATION. THE INTENDED PROCEDURE WAS ENDOBRONCHIAL ULTRASOUND-GUIDED TRANSBRONCHIAL NEEDLE ASPIRATION (EBUS-TBNA), AND THE USER COMPLETED THE PROCEDURE WITH THE DEVICE. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1212317 EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE BRONCHOFIBERVIDEOSCOPE PSV OLYMPUS MEDICAL SYSTEMS CORP. BF-UC190F

    Patients

    Seq Age Sex Outcome Treatment
    1