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

Model Number 478001000

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problems Airway Obstruction (1699); Foreign Body In Patient (2687)

Event Date 12/07/2021

Event Type  malfunction  

Event 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.

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
• Type of Device: FLEXIBLE VIDEO BRONCHOSCOPE
• Manufacturer (Section D): AMBUA/S; baltorpbakken 13; ballerup, dnk 2750 ; DA 2750
• MDR Report Key: 13238803
• MDR Text Key: 286673466
• Report Number: 1220828-2022-00001
• Device Sequence Number: 1
• Product Code: EOQ
• UDI-Device Identifier: 05707480135530
• UDI-Public: 05707480135530
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1