MAUDE Adverse Event Report: VERATHON MEDICAL ULC BFLEX 2 REGULAR 5.0 SINGLE-USE BRONCHOSCOPE

Model Number	0570-0423
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject bflex 2 regular 5.0 single-use bronchoscope was not returned to verathon for evaluation.Since the device was not made available for analysis, the exact cause of the reported image issue could not be determined.Review of complaint history for lot ks250904 did not identify any other complaints associated with this lot.Verathon confirmed that the risk associated with the reported scenario has been adequately captured and characterized in the system risk assessment.Trending analysis for the bflex 2 regular 5.0 single-use bronchoscope does not identify any trends exceeding acceptable limits.Corrective action is not required at this time.Verathon will continue to monitor for trends.
Event or Problem Description
A customer reported that during a patient procedure, a bflex 2 regular 5.0 single-use bronchoscope was plugged in alongside a laryngoscope blade for approximately 10 minutes during case setup.When the case began, the crna selected the bflex 2 regular 5.0 scope to intubate a patient with a known difficult airway.The scope was confirmed to be powered on with an image visible prior to use.Upon insertion into the patient's nose, the image briefly turned red/green and then immediately went black.The crna unplugged the scope and completed the intubation using a mac3 blade, which remained connected throughout.The blade video was not in use at the time of the issue (not a dual-view setup).A verathon clinical specialist was present in the room, retained the affected scope, and attempted to recreate the reported issue multiple times without success.An additional attempt to replicate the behavior was conducted the following morning, again with no recurrence.
Additional Manufacturer Narrative
B4, d9, g3, g6, h2, h3, h6, h11.The subject bflex 2 regular 5.0 single-use bronchoscope was returned to verathon for evaluation.A verathon technical service representative (tsr) evaluated the returned device but was unable to confirm the reported image issue.When connected to verathon's test equipment, the failure could not be duplicated.The system was powered with the bflex for over ten (10) minutes without issue.The bflex connection was manipulated but still no image issues were observed.The bflex passed both visual inspection and verathon's device functionality testing and confirmed to be within specification.The monitor and cable that were connected to the bflex during the reported incident were not made available to verathon for evaluation.Upon completion of verathon's device evaluation, the bflex was scrapped due to being a single-use device.No further investigation is required at this time.Verathon will continue to monitor for trends.

• Brand Name: BFLEX 2 REGULAR 5.0 SINGLE-USE BRONCHOSCOPE
• Common Device Name: BRONCHOSCOPE
• 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: 22720783
• Report Number: 9615393-2025-00086
• Device Sequence Number: 12962984
• Product Code: EOQ
• UDI-Device Identifier: 00879123008565
• UDI-Public: (01)00879123008565(10)KS250904(11)250228(17)280904
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K183256
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2025

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: 0570-0423
• Device Catalogue Number: 0570-0449
• Device Lot Number: KS250904
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2025
• Supplement Date Received by Manufacturer: 08/06/2025
• Initial Report FDA Received Date: 08/05/2025
• Supplement Report FDA Received Date: 08/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2025
• 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