MAUDE Adverse Event Report: Ambu A/S aScope 4 Broncho Large

Catalog Number	478001000
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Unintended Extubation (4564)
Date of Event	07/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reported customer complaint: parts of the bronchoscope have come loose inside the tube.The client informed us by email; sales rep contacted them by phone.The bronchoscope will be picked up on monday, and sales rep will speak with the senior physician in person.The patient was intubated with an 8.0 tube and then underwent bronchoscopy.During the procedure, the thoracic surgeon noticed that the bronchoscope "got stuck" in the tube.Upon withdrawing it, the thoracic surgeon discovered that the tip was still lodged in the tube.The patient was then reintubated; he was not harmed.The materials were forwarded to the purchasing department.The bronchoscope was inserted via a duckbill cuff with integrated suction and broke off inside the tube during the procedure.Fortunately, the patient was not harmed.The incident was detected due to unstable ventilation, allowing the patient to be reintubated immediately.
Additional Manufacturer Narrative
It was possible to verify the reported failure (parts of the bronchoscope have come loose inside the tube) from the photos and returned sample provided.Based on the investigation findings including simulation test to reproduce the issue, the cause is considered to be due to an unintended use error involving insufficient lubricant and withdrawal of the bronchoscope while the bending section was in a deflected (non-neutral) position resulting in increased resistance and subsequent detachment of the distal tip which remained lodged within the ett.The instruction for use guide the user to maintain the distal tip in a neutral, non-deflected position during withdrawal and not operate the control lever during removal.The production performs 100% inspection of the distal tip on each ascope4 broncho large manufactured.Production, technical team and quality control have been made aware of this feedback via a quality alert.

• 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: 50172087
• Report Number: 9610691-2026-00026
• Device Sequence Number: 15917778
• 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): 08/07/2026

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 Catalogue Number: 478001000
• Device Lot Number: 1001260094
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/22/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2026
• Initial Report FDA Received Date: 08/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown