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	Serious Injury
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.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.
Additional Manufacturer Narrative
The device was returned for investigation.We are able to verify the reported failure, the tip of the scope had broken, from the returned sample.Based on the investigation result, we are able to conclude that the tip of the scope was broken as per the reported failure due to the bending section of the scope not being in a straight (neutral) position, which resulted in excessive force being applied in order to remove the scope as the distal end was hooked to the tube.Ambu production and qc performs 100% visula inspection on each ascope 4 broncho slim and the scope was verified in good condition prior to shipment.Quality alert has been sent to industrial engineering, quality control and production to alert them on this market complaint.

• Brand Name: ASCOPE 4 BRONCHO SLIM
• Common Device Name: ASCOPE 4 BRONCHO SLIM
• Manufacturer (Section D): AMBU A/S; baltorpbakken 13; ballerup, dnk 2750 ; DA 2750
• MDR Report Key: 15382135
• Report Number: 1220828-2022-00012
• Device Sequence Number: 20249289
• Product Code: EOQ
• UDI-Device Identifier: 05707480135479
• UDI-Public: 05707480135479
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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): 09/08/2022
• Report Date (Section F): 08/11/2022

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: 476001000
• Device Catalogue Number: 476001000
• Device Lot Number: 1000606991
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/11/2022
• Event Location: Hospital
• Date Report to Manufacturer: 08/11/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/08/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown