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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
During a bronchoscopy procedure using an ascope 4 broncho large 5.8/2.8, the distal tip of the device detached.A second bronchoscopy was performed using a reusable bronchoscope to retrieve the detached part with biopsy forceps.The involved device has been retained by the hospital for investigation if required.Patient outcome: examination prolonged, with no serious consequences for the patient.
Additional Manufacturer Narrative
Based on the returned sample it was possible to verify the reported failure (distal tip detached).Further investigation was done by performing a simulation test of a good sample to assess the interaction between a sufficiently lubricated good sample and a good endotracheal tube (ett) under normal use conditions.The distal tip of good sample was inserted into and withdrawn through the good ett to identify any abnormalities that could contribute to the reported failure.The distal tip passed smoothly through the ett during insertion and withdrawal with no abnormal resistance.Additionally a simulation test was performed to assess the behaviour of the good sample under exaggerated use conditions.A minimal amount of lubricant was applied to the good sample and the bending control lever was activated to a deflected (non-neutral) position.The sample was subsequently withdrawn through the good ett while holding the bending control lever to determine any abnormalities that could contribute to the reported failure.Under the exaggerated use conditions, increased resistance was encountered during withdrawal of the sample through the good ett.Excessive force was required to withdraw the sample from the good ett and the distal tip detached from the main tube and remained inside the good ett.Based on the investigation findings, the cause of reported failure was due to unintended use error which likely involving insufficient lubrication and unintended holding of the bending control lever during withdrawal, resulting in the bending section remaining in a deflected (non-neutral) position.This causes the distal tip to come into contact with the inner wall of the ett, creating increased friction and resistance during removal.The additional withdrawal force required to overcome the increased resistance subsequently led to detachment of the distal tip.Instruction for use (ifu) for ascope 4 broncho (lbl-004917 rev 7) is in place to guide the user that the distal tip must be in a neutral, non-deflected position during withdrawal and the control lever must not be operated as this may result in patient injury and/or damage to the endoscope.Ambu production and qc perform 100% distal tip inspection on each ascope4 broncho large.Production, technical team and quality control have been made aware of this feedback via quality alert.

• Brand Name: aScope 4 Broncho Large
• Common Device Name: aScope 4 Broncho Large
• Manufacturer (Section D): Ambu A/S; baltorpbakken 13; ballerup, 2730 ; DA 2730
• 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: 50564938
• Report Number: 9610691-2026-00027
• Device Sequence Number: 9927695
• Product Code: EOQ
• UDI-Device Identifier: 05707480135530
• UDI-Public: 05707480135530
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/02/2026

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: 1001295502
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/17/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2026
• Initial Report FDA Received Date: 09/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2026
• 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