BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRONCHOVIDEOSCOPE

    MDR report key: 12588877 · Received October 7, 2021

    Report

    Report Number
    8010047-2021-12841
    Event Type
    Malfunction
    Date Received
    October 7, 2021
    Report Date
    February 18, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    EOQ
    UDI-DI
    04953170288968
    PMA / PMN Number
    K023984
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A SUPPLEMENTAL REPORT TO CORRECT AWARE DATE. THE CORRECT AWARE DATE WAS SEPTEMBER 17, 2021, NOT SEPTEMBER 16, 2021 AS REPORTED IN INITIAL MDR.

    Description of Event or Problem · 0

    THIS SUPPLEMENTAL REPORT WAS SUBMITTED TO PROVIDE ADDITIONAL INFORMATION REGARDING THE EVENT (B5). THE BIOMEDICAL ENGINEER AT THE USER FACILITY FURTHER REPORTED THAT THE INITIAL REPORTED EVENT OCCURRED DURING PREPARATION FOR USE.

    Additional Manufacturer Narrative · 1

    LOCAL SERVICE DEPARTMENT CHECKED THE SUBJECT DEVICE AND FOUND THE PHENOMENON.THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME.IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT DURING THE INCOMING INSPECTION FOR REPAIR AT LOCAL SERVICE DEPARTMENT OF OLYMPUS ON SEPTEMBER 16, 2021, THERE WAS LOOSENESS / DEFORMATION / SCRAPING / RATTLING / DETACHMENT OF INSTRUMENT CHANNEL PORT DUE TO PHYSICAL STRESS. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1491752 BRONCHOVIDEOSCOPE BRONCHOVIDEOSCOPE EOQ OLYMPUS MEDICAL SYSTEMS CORP. BF-1T150 04953170288968

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown