MAUDE Adverse Event Report: AMBU A/S ASCOPE 4 BRONCHO SLIM

Model Number	476001000
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned for investigation, therefore retention sample has been retrieved to assist for investigation.When verifying on retention sample by inserting sufficient lubricated insertion cord to 35 fr double lumen tube.The reported failure could not be verified from retention sample.The lubricated insertion cord able to move smoothly within the intubation tube.The scope being stuck in the tube is most likely due to insufficient lubrication followed by the user using excessive force to remove out the scope from the tube causing the distal end to break during removal.Device received for investigation 06-sep-2022.Further investigation to confirm the reported failure will be conducted.In case conclusion is changed based on the device investigation a follow-up report will be submitted.
Event or Problem Description
While attempting to confirm proper positioning of a double lumen endotracheal tube with a disposable bronchoscope, it was noted bronchoscope appeared to be stuck while through ett.While attempting to confirm proper positioning of a double lumen endotracheal tube with a disposable bronchoscope, it was noted bronchoscope appeared to be stuck while through ett.The bronchoscope was inserted slightly further and then pulled back.There was a loss of resistance but on withdrawal it was noted the scope was broken with exposed wires.A new bronchoscope was inserted and the distal tip of previous broken bronchoscope was found in right middle lobe bronchus.Procedure was proceeded.At the end the surgeon went in with forceps and removed the broken tip easily.There was no sign of trauma of any sort to the airway, and the piece came out without resistance.

• Brand Name: ASCOPE 4 BRONCHO SLIM
• Common Device Name: ASCOPE 4 BRONCHO SLIM
• Manufacturer (Section D): AMBU A/S; baltorpbakken 13; ballerup, denmark 2750 ; DA 2750
• Manufacturer (Section G): AMBU SDN. BHD.; 69 b, lintang bayan lepas 6, p; bayan, lepas, pulau pinang 11900 ; MY 11900
• Manufacturer Contact: kristine rasmussen ; baltorpbakken 13; ballerup, denmark 2750 ; DA 2750
• MDR Report Key: 15376512
• Report Number: 9610691-2022-00012
• Device Sequence Number: 5402825
• Product Code: EOQ
• UDI-Device Identifier: 05707480135479
• UDI-Public: 05707480135479
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/07/2022

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: 476001000
• Device Catalogue Number: 476001000
• Device Lot Number: 1000606991
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2022
• Initial Report FDA Received Date: 09/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/30/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown