MAUDE Adverse Event Report: VERATHON MEDICAL ULC BFLEX 2 LARGE 5.8 SINGLE-USE BRONCHOSCOPE; BRONCHOSCOPE (FLEXIBLE OR RIGID)

Model Number	0570-0424
Medical Device Problem Codes	Degraded (1153); Flaked (1246); Material Frayed (1262); Material Deformation (2976)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Following the reported event, the customer's verathon territory manager visited the facility to investigate the reported event and gather the sample to be returned to verathon for evaluation.During the verathon territory manager's site visit, it was identified that this device was likely exposed to ultraviolet (uv) cleaning lights present in the department prior to its use in the procedure.The bflex 2 single-use bronchoscopes operations and maintenance manual (omm) contains a caution which states, "do not store bflex 2 pouches in direct sunlight." the facility was reminded not to store bflex devices in the rooms containing the uv cleaning lights when not in use.The bflex 2 large 5.8 single-use bronchoscope used during the reported event was returned to verathon for evaluation.Visual inspection confirmed the reported sheath damage at the bronchoscope's distal end.Review of complaint history for similar events found a prior investigation that verathon conducted on samples of the first and second generation of bflex single-use bronchoscopes.In an effort to recreate the prior material deterioration issue noted on the subject device, samples were placed in a 405 nm led uv curing chamber for 28 minutes.The material flaking was duplicated following the exposure to the uv light.Upon completion of verathon's device evaluation, the device was scrapped due to being a single-use device.The customer's verathon territory manager has provided replacement bronchoscopes to the facility and indicated that further communication will be created within the department regarding uv exposure.Trending analysis for bflex 2 single-use bronchoscopes does not identify any trends exceeding acceptable limits.Verathon confirmed that the risk associated with the hazardous scenario has been adequately captured and characterized per the system risk assessment.Corrective action is not required at this time.Verathon will continue to monitor for trends.
Event or Problem Description
A customer reported the distal tip of a bflex 2 large 5.8 single-use bronchoscope deteriorated during suctioning through a 7.5 shiley hi-low endotracheal tube.A backup bflex 2 regular 5.0 single-use bronchoscope was used to complete additional suctioning and removal of the detached pieces.No additional pulmonary procedure was required and the patient was confirmed to be fine.

• Brand Name: BFLEX 2 LARGE 5.8 SINGLE-USE BRONCHOSCOPE
• Common Device Name: BRONCHOSCOPE (FLEXIBLE OR RIGID)
• Manufacturer (Section D): VERATHON MEDICAL ULC; 2227 douglas road; burnaby, british columbia V5C 5 A9; CA V5C 5A9
• Manufacturer (Section G): VERATHON MEDICAL ULC; 2227 douglas road; burnaby, british columbia V5C 5 A9; CA V5C 5A9
• Manufacturer Contact: corey kasbohm ; 20001 n creek pkwy; bothell, WA 98011-8218 ; 4256295760
• MDR Report Key: 23819009
• Report Number: 9615393-2025-00137
• Device Sequence Number: 15804963
• Product Code: EOQ
• UDI-Device Identifier: 00879123008572
• UDI-Public: (01)00879123008572(10KT240700(11)240212(17)260216
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K191948
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/16/2025

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 Expiration Date: 02/16/2026
• Device Model Number: 0570-0424
• Device Catalogue Number: 0570-0450
• Device Lot Number: KT240700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2025
• Initial Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2024
• 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: Required Intervention
• Patient Sex: Unknown