MAUDE Adverse Event Report: AMBUA/S AMBU ASCOPE 4 BRONCHO LARGE; FLEXIBLE VIDEO BRONCHOSCOPE

Model Number	478001000
Health Effect - Clinical Codes	Airway Obstruction (1699); Foreign Body In Patient (2687)
Date of Event	12/07/2021
Type of Reportable Event	Malfunction
Event or Problem Description
An ascope 4 broncho was used in combination with a shiley evac oral tracheal tube.When the ascope 4 broncho large was pulled out, the tip of the bronchoscope teared off.The bending piece got stuck in the tube and caused an airway obstruction.The user has confirmed that the tracheal tube was bent during the procedure.
Additional Manufacturer Narrative
The tip of the bronchoscope tearing off was due to the user bending the et tube, causing this section of the ascope to not be in a straight position during removal of the scope.Thus, user applied excessive force to remove the scope from the tube causing the ascope bending section to tear off during removal of the scope.Further, according to the ifu for ascope 4 broncho family the user should always make sure that the bending section is in a straight position (neutral/non-deflected) and excessive force should not be used when withdrawing the endoscope.The product risk evaluation has been evaluated and the risk is assessed as acceptable.No remedial, corrective or preventive actions are taken as a result of this event.Ambu will keep monitoring this issue and take actions if necessary.

• Brand Name: AMBU ASCOPE 4 BRONCHO LARGE
• Common Device Name: FLEXIBLE VIDEO BRONCHOSCOPE
• Manufacturer (Section D): AMBUA/S; baltorpbakken 13; ballerup, dnk 2750 ; DA 2750
• MDR Report Key: 13238803
• Report Number: 1220828-2022-00001
• Device Sequence Number: 20134151
• Product Code: EOQ
• UDI-Device Identifier: 05707480135530
• UDI-Public: 05707480135530
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 478001000
• Device Catalogue Number: 478001000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/15/2021
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/12/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown