MAUDE Adverse Event Report: AMBU A/S ASCOPE 4 BRONCHO LARGE SAMPLER SET; SINGLE-USE BRONCHOSCOPE

Model Number	478501000
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Sample is currently with the healthcare facility, however has been requested for investigation.Investigation of the complaint is currently on-going at the manufacturing site.A follow-up mdr report will be submitted when the investigation has been completed.
Event or Problem Description
Customer reported, that while performing an alveolar lavage during bronchial fibroscopy, rubber occlusive membrane of the fiberscope's operating channel ruptured and part of it fell into patient's bronchial tree.They were not able to recover it.Patient was admitted to intensive care unit for respiratory distress and undergone fibrescopy on the same day.Patient continued to be hospitalized in intensive care and actions were taken in the hospital to manage the patient.
Additional Manufacturer Narrative
Sample is currently with the healthcare facility, however has been requested for investigation.Investigation of the complaint is currently on-going at the manufacturing site.A follow-up mdr report will be submitted when the investigation has been completed.Follow-up #1 01-10-2025.D9 - device not available for investigation.G3 - date updated for when the investigation results became available.H6 - coding modified for annex b, c and d.H10 - importer report number added.H11 : we are unable to verify the reported failure as the actual sample nor pictures were returned for investigation.Since the failure happened during alveolar lavage procedure, we suspect that endotracheal tube (ett) was used in order to isolate lungs and prevent fluid leakage into the ventilated lung.Retention sample from the same lot was retrieved for testing and it was confirmed that lubricated sample could smoothly pass through compatible ett.Simulation test was conducted by pulling out the scope of ett while bending section was not in neutral position and with minimal lubrication and damage to the bending section was observed.It is suspected that the possible cause of reported failure was that there was insufficient lubrication and that the bending section of the working channel was not in neutral position while removing the scope from ett with excessive force.However, the root cause could not be established due to insufficient information.Ambu production and quality performs 100% visual inspection and bending functionality inspection on each of the scope prior shipment.Ifu states: 'when withdrawing the endoscope, the distal tip must be in neutral and non-deflected position.' and 'lubricate the insertion cord with a medical grade lubricant when the endoscope is inserted into the patient.' quality alert has been raised to industrial engineering, production and quality control to alert them on this market complaint.We will continue monitoring the market for similar complaints.
Event or Problem Description
Customer reported, that while performing an alveolar lavage during bronchial fibroscopy, rubber occlusive membrane of the fiberscope's operating channel ruptured and part of it fell into patient's bronchial tree.They were not able to recover it.Patient was admitted to intensive care unit for respiratory distress and undergone fibrescopy on the same day.Patient continued to be hospitalized in intensive care and actions were taken in the hospital to manage the patient.

• Brand Name: ASCOPE 4 BRONCHO LARGE SAMPLER SET
• Common Device Name: SINGLE-USE BRONCHOSCOPE
• 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, 11900 ; MY 11900
• Manufacturer Contact: lenka vaculciakova ; baltorpbakken 13; ballerup, 2750 ; DA 2750
• MDR Report Key: 21033956
• Report Number: 9610691-2024-00028
• Device Sequence Number: 18430826
• Product Code: EOQ
• UDI-Device Identifier: 05707480146017
• UDI-Public: 05707480146017
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K210883
• 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,Followup
• Report Date (Section B): 01/10/2025

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: 478501000
• Device Catalogue Number: 478501000
• Device Lot Number: 1000903368
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2024
• Supplement Date Received by Manufacturer: 01/09/2025
• Initial Report FDA Received Date: 12/30/2024
• Supplement Report FDA Received Date: 01/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/23/2023
• 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