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

Model Number	478001000
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Airway Obstruction (1699)
Date of Event	12/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The tip of the bronchoscope teared off was due to the user who bent the et tube, this caused that the bending section of the ascope was not 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 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.
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.

• Brand Name: AMBU ASCOPE 4 BRONCHO LARGE
• Common Device Name: FLEXIBLE VIDEO BRONCHOSCOPE
• Manufacturer (Section D): AMBU A/S; baltorpbakken 13; ballerup, 2750 ; DA 2750
• Manufacturer (Section G): AMBU A/S; baltorpbakken 13; ballerup, 2750 ; DA 2750
• Manufacturer Contact: lena søndergaard ; baltorpbakken 13; ballerup, 2750 ; DA 2750
• MDR Report Key: 13225304
• Report Number: 9610691-2021-00020
• Device Sequence Number: 3868558
• Product Code: EOQ
• UDI-Device Identifier: 05707480135530
• UDI-Public: 05707480135530
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K173727
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/11/2022

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2021
• Initial Report FDA Received Date: 01/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown