BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASCOPE 4 BRONCHO REGULAR

    MDR report key: 11848417 · Received May 19, 2021

    Report

    Report Number
    9610691-2021-00007
    Event Type
    Injury
    Date Received
    May 19, 2021
    Date of Event
    March 24, 2021
    Report Date
    April 21, 2021
    Manufacturer
    AMBU A/S
    Product Code
    EOQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE DOCTOR WAS PERFORMING A BRONCHOSCOPY BED PROCEDURE TO A PATIENT WITH TRACHEOSTOMY. THE PATIENT WAS PRESENTING STENOSIS AT LOWER LEFT LOBAR BRONCHUS. IN ORDER TO OVERCOME THE STENOSIS THE DOCTOR NEEDED TO APPLY MORE PRESSURE AND FORCE. HE WAS ABLE TO OVERCOME THE STENOSIS BUT WHEN THEY NEEDED TO REMOVE THE BRONCHOSCOPE THE DOCTOR NOTICED A RESISTANCE. THE BRONCHOSCOPE COLLAPSED AND THE DOCTOR WAS NOT ABLE TO REMOVE IT. TO BE ABLE TO REMOVE THE BRONCHOSCOPE THE TRACHEOSTOMY TUBE HAD TO BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745167 ASCOPE 4 BRONCHO REGULAR FLEXIBLE VIDEO BRONCHOSCOPE, SINGLE-USE EOQ AMBU A/S 476001000 1000427378

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention