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	Unintended Extubation (4564)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was possbile to verify the reported failure (the distal tip remained lodged in the endotracheal tube) from the returned sample.From the investigation performed, the possible cause of reported failure could be due to the bending section not being in neutral position and insufficient lubricant when removing the scope from et tube.This can have resulted in the distal end was teared off and remained in the et tube.According to ifu (lbl-004917 rev.6.) is it stated that the distal tip must be in neutral and non-deflected position when withdrawing the endoscope.Ambu production and qc performed 100% inspection on each scope to ensure the product is in good condition before shipment.An quality alert has been raised to the technical team, quality control and production on this market complaint.
Event or Problem Description
While withdrawing the bronchoscope without resistance, the distal tip remained lodged in the endotracheal tube.The intensive care patient subsequently had to be reintubated.The patient was deeply sedated, did not strain, and the bronchoscopy was performed without difficulty and with good visibility.Patient outcome was 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: 23579167
• Report Number: 9610691-2025-00028
• Device Sequence Number: 21226950
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/18/2025

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: 1001146219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2025
• Initial Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2025
• 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