MAUDE Adverse Event Report: AMBU A/S ASCOPE¿ 4 BRONCHO LARGE SAMPLER SET 5.8/2.8; ASCOPE 4 BRONCHO LARGE SAMPLER SET

Catalog Number	478501000
Medical Device Problem Code	Suction Failure (4039)
Health Effect - Clinical Code	Hypoxia (1918)
Date of Event	07/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The ascope did not suction during use.This malfunction caused a delay in resolving atelectasis in a patient.To continue caring for the patient, the medical team had to urgently replace the fiberscope with another device of the same model and lot, which worked properly.Additional information received on 18aug2025: during a bronchial clearance fibroscopy, the fibroscopy equipment stopped suctioning.A complete check of the suction line was carried out, without revealing any upstream failure.The patient, already experiencing desaturation, required a change of fibroscope.A device from the same batch was then used and functioned correctly.However, this incident led to a temporary worsening of desaturation, as well as a delay in clearing the obstruction in a patient with acute lobar pneumonia.
Additional Manufacturer Narrative
We were unable to verify the reported failure (no suction) as complaint sample was not returned for investigation.We have reached out to the customer to request further information, however no reply was received.Manufacturing records of the reported lot were reviewed and no abnormalities were identified.Based on risk document, the possible cause of failure could be due to distal end of working channel was block due to secretion, thus caused no suction.However, we are unable to comment further as no sample returned for investigation.Ambu production perform 100% flow test inspection on each ascope to ensure the products is in good condition before shipment.Production, technical team and quality control have been aware of this feedback via quality alert and we will continue monitoring the market for similar incidents.

• Brand Name: ASCOPE¿ 4 BRONCHO LARGE SAMPLER SET 5.8/2.8
• Common Device Name: ASCOPE 4 BRONCHO LARGE SAMPLER SET
• 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, mys 1900, ; MY 1900,
• Manufacturer Contact: catharina engelhardt ; baltorpbakken 13; ballerup, 2750 ; DA 2750
• MDR Report Key: 23060420
• Report Number: 9610691-2025-00022
• Device Sequence Number: 10044521
• 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: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/16/2025

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 Catalogue Number: 478501000
• Device Lot Number: 1001074150
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2025
• Initial Report FDA Received Date: 09/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/11/2024
• 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