BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA ULTRASONIC BRONCHOFIBERVIDEOSCOPE

    MDR report key: 11121729 · Received January 5, 2021

    Report

    Report Number
    8010047-2021-00904
    Event Type
    Malfunction
    Date Received
    January 5, 2021
    Date of Event
    December 8, 2020
    Report Date
    February 5, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    PSV
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORPORATION (OMSC) FOR EVALUATION. THERE WERE NO FURTHER DETAILS PROVIDED. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) COULD NOT INVESTIGATE THE DEVICE, BECAUSE THE DEVICE WAS NOT RETURNED TO OMSC. THIS IS ASSUMED TO HAVE OCCURRED DUE TO THE HANDLING OF THE DEVICE DEVIATING FROM THE CONTENTS OF THE INSTRUCTION MANUAL BY THE USER.

    Description of Event or Problem · 1

    DURING REPROCESS WITH THE DEVICE, THE USER DID NOT BRUSH THE BALLOON CHANNEL OF THE DEVICE. OTHER DETAILED INFORMATION WAS NOT PROVIDED. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18039 EVIS LUCERA ULTRASONIC BRONCHOFIBERVIDEOSCOPE ULTRASONIC BRONCHOFIBERVIDEOSCOPE PSV OLYMPUS MEDICAL SYSTEMS CORP. BF-UC260FW

    Patients

    Seq Age Sex Outcome Treatment
    1