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

Model Number	SLIM
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
During procedure the tip of the scope got stuck in the hub of a double lumen tube.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.
Additional Manufacturer Narrative
The device is not yet received for investigation.Based on information it is concluded that correct size dlt was used (37fr).According to 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.

• Brand Name: ASCOPE 4 BRONCHO SLIM
• Common Device Name: ASCOPE 4 BRONCHO SLIM
• Manufacturer (Section D): AMBU A/S; baltorpbakken 13; ballerup, 2750 ; DA 2750
• Manufacturer (Section G): AMBU SDN.BHD; lot 69-b; lintang bayan lepas, phase iv; penang, 11900 ; MY 11900
• Manufacturer Contact: kristine rasmussen ; baltorpbakken 13; ballerup, 2750 ; DA 2750
• MDR Report Key: 16276618
• Report Number: 9610691-2023-00003
• Device Sequence Number: 6390866
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/30/2023

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2023
• Initial Report FDA Received Date: 02/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Other
• Patient Sex: Unknown