BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASCOPE 4 BRONCHO REGULAR

    MDR report key: 11986700 · Received June 11, 2021

    Report

    Report Number
    1220828-2021-00007
    Event Type
    Injury
    Date Received
    June 11, 2021
    Date of Event
    March 24, 2021
    Report Date
    April 22, 2021
    Manufacturer
    AMBU A/S
    Product Code
    EOQ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE WAS RETURNED FOR INVESTIGATION. THE REPORTED FAILURE WAS ABLE TO BE VERIFIED (ENDOSCOPE STUCK/BROKE) FROM THE PICTURE PROVIDED. THE CAUSE OF THE REPORTED FAILURE IS THE USER APPLIED MORE PRESSURE AND FORCE TO OVERCOME THE STENOSIS DURING BRONCHOSCOPY. THIS MDR IS RESUBMITTED AGAIN AS IT WAS IDENTIFIED THAT ORIGINAL SUBMISSION HAD NOT BEEN SUCCESSFULLY LOADED INTO THE FDA DATABASE DUE TO WRONG FILE FORMAT. THE INITIAL MDR OF THIS INCIDENT WAS SUBMITTED TO THE FDA WITHIN THE ORIGINAL REPORTING DEADLINE. THIS SUBMISSION REPRESENTS A RELOAD OF DATA TO ENSURE CORRECT UPLOAD TO THE FDA DATABASE.

    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
    877500 ASCOPE 4 BRONCHO REGULAR FLEXIBLE VIDEO BRONCHOSCOPE, SINGLE-USE EOQ AMBU A/S 476001000 1000427378

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention