MAUDE Adverse Event Report: AMBU A/S ASCOPE 5 BRONCHO 2.7/1.2

Model Number	624001000US
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
During investigation it was possible to verify the reported failure (endoscope distal tip broke off) from the photos provided.No samples was returned for investigation.The possible cause for the reported failure could be due to the distal end becoming bent and lodged inside the dlt, resulting in breakage during withdrawal.According to the ifu, the distal tip must be in a non-deflected position when withdrawing the endoscope, and the control lever should not be operated during withdrawal.Ambu production and qc performs 100% visual inspection on the ascope and the 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 vats surgical procedure that our a5 2.7mm endoscope distal tip broke off into the patients endotracheal tube.Anesthesia team went in and retrieved the piece that had broken off.Patient condition was not affected by the failure.
Event or Problem Description
During a vats surgical procedure that our a5 2.7mm endoscope distal tip broke off into the patients endotracheal tube.Anesthesia team went in and retrieved the piece that had broken off.Patient condition was not affected by the failure.
Additional Manufacturer Narrative
Initial mdr report: during investigation it was possible to verify the reported failure (endoscope distal tip broke off) from the photos provided.No samples was returned for investigation.The possible cause for the reported failure could be due to the distal end becoming bent and lodged inside the dlt, resulting in breakage during withdrawal.According to the ifu, the distal tip must be in a non-deflected position when withdrawing the endoscope, and the control lever should not be operated during withdrawal.Ambu production and qc performs 100% visual inspection on the ascope and the 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.Follow-up mdr report: actual device was received for investigation december 15, 2025 and the already conducted investigation results was therefore revised.Based on the returned sample it was now possible to also verify the reported failure (endoscope distal tip broke off) from the returned sample.The possible cause for the reported failure could be due to the distal end becoming bent and lodged inside the dlt, resulting in breakage during withdrawal.The codes for type of investigation, investigation findings and investigation conclusion in h6 have been updated accordingly.

• Brand Name: ASCOPE 5 BRONCHO 2.7/1.2
• Common Device Name: ASCOPE 5 BRONCHO 2.7/1.2
• 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: 23740214
• Report Number: 9610691-2025-00030
• Device Sequence Number: 10209701
• Product Code: EOQ
• UDI-Device Identifier: 05707480157280
• UDI-Public: 05707480157280
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K233671
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2026

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: 624001000US
• Device Lot Number: 1001106302
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2025
• Supplement Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2024
• 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: Required Intervention
• Patient Sex: Unknown