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

Model Number	478001000
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
Additional Manufacturer Narrative
During investigation it was possible to verify the reported failure (distal end of the bronchoscope was torn off) from returned sample.Based on the simulation test performed, the possible cause of the reported failure could be due to the bending section was not in neutral position when removing the scope from the et tube with excessive force, resulting in the distal end was torn.The production performs 100% inspection on each ascope and this scope was verified in good condition prior to shipment production, technical team and quality control have been made aware of this feedback via quality alert.
Event or Problem Description
During a bronchoscopy for secretion retention, the distal end of the bronchoscope was torn off.The endoscope was disposed of.Only the distal end was retained and will be sent in.Patient outcome not affected.

• Brand Name: ASCOPE 4 BRONCHO LARGE
• Common Device Name: ASCOPE 4 BRONCHO LARGE
• Manufacturer (Section D): AMBU A/S; baltorpbakken 13; ballerup, 2750 ; DA 2750
• Manufacturer (Section G): AMBU SDN. BHD.; lot 69-b, lintang; bayan lepas 6, phase iv; penang, 1900 ; MY 1900
• Manufacturer Contact: bolette walldorf ; baltorpbakken 13; ballerup, 2750 ; DA 2750
• MDR Report Key: 23531395
• Report Number: 9610691-2025-00027
• Device Sequence Number: 9047638
• Product Code: EOQ
• UDI-Device Identifier: 05707480135530
• UDI-Public: 05707480135530
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/12/2025

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: 478001000
• Device Lot Number: 1001150033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2025
• 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
• Patient Sex: Unknown