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	02/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer did not retain the subject bflex 2 regular 5.0 single-use bronchoscope to have it returned to verathon for evaluation; therefore the cause of the reported image issue could not be determined.The customer reported that they have communicated with their facility staff to keep any other bronchoscopes that may have issues to have them sent to verathon for failure analysis.To date, no additional similar complaints have been reported by the customer.Review of complaint history for the subject lot of bronchoscopes could not be performed as no lot number was provided.Trending analysis for bflex 2 regular 5.0 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 while performing a bronchoalveolar lavage (bal) bronchoscopy with a bflex 2 regular 5.0 single-use bronchoscope, the picture on the screen frizzed out when injecting the bolus.They reported the picture snowed out and displayed tracking lines, obscuring about 90% of the image.While it was reported that this event happened during instillation of saline via 60cc syringe, it persisted after the syringe was emptied and when suctioning.The bronchoscope was removed and switched to a new one.After completing the bronchoscopy, the customer reconnected the affected bronchoscope and reported it functioned normally.No delay in the procedure or harm to the patient was reported.

• 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: 21537682
• Report Number: 9615393-2025-00023
• Device Sequence Number: 7735965
• Product Code: EOQ
• UDI-Device Identifier: 00879123008565
• UDI-Public: 00879123008565
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/14/2025

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: UNKNOWN
• 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: 02/14/2025
• Initial Report FDA Received Date: 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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