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

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)
Date of Event	01/09/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Verification of the reported failure was performed based on photos provided by the customer, where white piece of plastic was depicted.Based on additional information provided by the customer, no tools, et tube nor any accessories were used with the scope and user did not feel any restriction when inserting or removing the scope.Pre-check did not reveal any abnormalities.A retention sample from other lot was retrieved for a simulation of the incident.The scope was inserted into a dummy's mouth and intentional biting was performed combined with a rough removal of the scope.It was observed that a piece of plastic cover on distal end almost tore off.Based on these investigation result, the possible cause of reported failure could be due to rough removal of the scope while the distal end was bitten.However, since no sample was returned for investigation, the actual root cause cannot be determined.The instructions for use (ifu) cautions users to be careful when handling the distal tip and not to allow it to strike other objects, as it may result in damage to the equipment.Additionally, the ifu states 'it is recommended to use a mouthpiece to protect the endoscope from being damaged.'.As the production performs qc inspection of each of the scopes prior to shipment.Quality alert has been raised to production, quality control and technical team to alert them on this market complaint.This is the first complaint received in the past year on intubation tube damage.Ambu will continue monitoring the market feedback regarding this failure.
Event or Problem Description
As per the customer, patient was endoscoped few times on this occasion there was a piece of plastic in patients' bronchus which they removed, it looked like a piece of our scope.The doctor discovered a white circular piece of plastic in patient`s trachea when he was doing a follow-up bronchoscopy, same scope had been used on the same patient few hours before.Piece of plastic was white and looked like piece from the end of the scope.Unfortunately, scope as well as the piece was thrown away and customer does not know the lot number either.

• Brand Name: ASCOPE 4 BRONCHO LARGE
• Common Device Name: VIDEO BRONCHOSCOPE
• 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: 24301740
• Report Number: 9610691-2026-00002
• Device Sequence Number: 13181371
• Product Code: EOQ
• UDI-Device Identifier: 05707480135530
• UDI-Public: 05707480135530
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/10/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 478001000
• Device Catalogue Number: 478001000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2026
• Initial Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown