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	07/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported bflex 2 regular 5.0 single-use bronchoscope has not yet been returned to verathon for evaluation.At the time of this report, the device is still pending return from the facility.As a result, the investigation is ongoing and the cause of the reported image issue has not been determined.Verathon reviewed complaint history for lot ks251800 and did not identify any similar complaints associated with this lot.Trending analysis for the bflex 2 regular 5.0 single-use bronchoscope does not identify any trends exceeding acceptable limits.Verathon confirmed that the risk associated with the reported scenario has been adequately captured and characterized per the system risk assessment.A supplemental report will be submitted in accordance with 21 cfr 803.56 if additional information becomes available.
Event or Problem Description
A customer reported that during a bronchoscopy procedure in the icu using a bflex 2 regular 5.0 single-use bronchoscope with a glidescope core 15-inch fhd monitor, the bronchoscope image went black and displayed colored lines.The bronchoscope was removed from the airway and cleaned, but the issue persisted.The device was taken out of service, and the procedure was completed using a new bronchoscope from a different lot.No harm to the patient was reported.The facility attempted to recreate the issue using the same and different components but was unable to replicate the failure.
Additional Manufacturer Narrative
B4, d9, g3, g4, g6, h2, h3, h6, h11.The customer's bflex 2 regular 5.0 single-use bronchoscope was returned to verathon for evaluation along with the glidescope core 15-inch fhd monitor and two (2) glidescope core 2m quickconnect cables used during the reported event.A verathon technical service representative (tsr) evaluated the returned devices but was unable to confirm the reported image issue.First, when connecting the customer's monitor to verathon's test equipment, the tsr tried wiggling the connections, detaching and reattaching the test devices, power-cycling the monitor with test devices attached, and swapping the test devices between the a and b ports.No image issues were observed with the cusotmer's monitor.Next, the customer's cables were tested but no image issues were found.Lastly, the customer's bflex was tested and again, no image issues were observed.All of the customer's devices passed verathon's device functionality testing and confirmed to be within specification.Upon completion of verathon's device evaluation, the monitor and both cables were returned to the customer.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: 22720784
• Report Number: 9615393-2025-00087
• Device Sequence Number: 8805112
• Product Code: EOQ
• UDI-Device Identifier: 00879123008565
• UDI-Public: (01)00879123008565(10)KS251800(11)250428(17)280502
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Administrator/Supervisor
• 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: KS251800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2025
• Supplement Date Received by Manufacturer: 08/04/2025
• 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: 04/28/2025
• 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