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

Model Number	SLIM
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not yet received for investigation.Based on information it is concluded that the correct size dlt was used (37fr).According to the customer the scope got stuck in dlt during insertion and the tip of the scope was in neutral position during insertion.Based on this information it is suspected that the scope got stuck due to insufficient lubrication or that the lubrication dried up causing the tip of the scope to get stuck.
Event or Problem Description
During procedure the tip of the scope got stuck in the hub of a double lumen tube.The anesthesiologist was unable to move the scope or pull it out in order to ventilate the patient.The tip of the scope broke in the dlt.No harm to patient.

• 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: 16279594
• Report Number: 1220828-2023-00002
• Device Sequence Number: 12505661
• 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): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/01/2023
• Report Date (Section F): 01/03/2023

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: SLIM
• Device Catalogue Number: 476001000
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/03/2023
• Event Location: Hospital
• Date Report to Manufacturer: 01/03/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/01/2023
• 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: Other
• Patient Sex: Unknown