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

Model Number	477001000
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Airway Obstruction (1699)
Date of Event	02/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is currently ongoing, we will submit a follow-up report as soon as the investigation is finalized.
Event or Problem Description
During minimal invasive ivor lewis procedure, after performing multiple bronchoscopies intraoperatively, the end of the single-use fiber optic suddenly got stuck in the double lumen tube.As per the customer, this was because the tube simply fell apart.No application of force.The tip simply fell off and blocked the tube, making ventilation impossible.The patient then had to be intubated.The patient has not suffered any damage as a result of this incident.
Event or Problem Description
During minimal invasive ivor lewis procedure, after performing multiple bronchoscopies intraoperatively, the end of the single-use fiber optic suddenly got stuck in the double lumen tube.As per the customer, this was because the tube simply fell apart.No application of force.The tip simply fell off and blocked the tube, making ventilation impossible.The patient then had to be intubated.The patient has not suffered any damage as a result of this incident.
Additional Manufacturer Narrative
The investigation is currently ongoing; we will submit a follow-up report as soon as the investigation is finalized.Follow-up report 04-04-2025.B4: date of this report, g6: follow-up report #1, h2: device evaluation, h6: coding for investigation findings and cause of failure updated based on investigation results, h10: updated, h11: we verified the reported failure from the returned sample.The customer returned for investigation one ascope 4 broncho regular with detached distal tip stuck inside shiley's 41 fr double lumen tube (dlt).Visual inspection of the returned sample revealed that the distal end broke at the bending section with both steering and camera wires still attached to the main tube.Sufficient glue was observed between the main tube and the distal end, ruling out that the failure was linked to assembly process.Maximum diameter of insertion portion of ascope 4 broncho regular is 5.5mm, which is compatible with minimum dlt size of 41 fr according to the instructions for use, thus compatible with shiley's dlt 41 fr.The returned shiley's dlt 41 fr was measured using digital caliper revealing the inner diameter of 5.35mm, while the inner diameter specification is stated as 5.4 mm on the product website.Therefore, based on investigation results, the cause of reported failure was the mismatch between the inner diameter of dlt (5.35mm) tube and maximum outer diameter of ascope 4 broncho regular (5.5mm), which lead to the scope getting stuck inside the tube an as user pulled the scope, the distal end broke off.

• Brand Name: ASCOPE 4 BRONCHO REGULAR
• Common Device Name: ASCOPE 4 BRONCHO REGULAR
• Manufacturer (Section D): AMBU A/S; baltorpbakken 13; ballerup, 2750 ; DA 2750
• Manufacturer (Section G): AMBU SDN. BHD.; lot 69b lintang bayan lepas 6; phase iv; penang, 11900 ; MY 11900
• Manufacturer Contact: lenka vaculciakova ; baltorpbakken 13; ballerup, 2750 ; DA 2750
• MDR Report Key: 21643683
• Report Number: 9610691-2025-00002
• Device Sequence Number: 18030878
• Product Code: EOQ
• UDI-Device Identifier: 05707480135509
• UDI-Public: 05707480135509
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 477001000
• Device Lot Number: 1001046284
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2025
• Supplement Date Received by Manufacturer: 02/18/2025
• Initial Report FDA Received Date: 03/19/2025
• Supplement Report FDA Received Date: 04/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2024
• 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: Other; Required Intervention
• Patient Sex: Unknown