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

Model Number	0570-0423
Medical Device Problem Codes	Off-Label Use (1494); Failure to Advance (2524); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported during a patient procedure, a bflex 2 regular 5.0 single-use bronchoscope became lodged in a 39 fr double-lumen tube (dlt).The patient ended up having to be reintubated as a result after removing the dlt with the bronchoscope still stuck in the tube.No delay in the procedure or harm to the patient was reported.
Additional Manufacturer Narrative
The customer was unable to have the reported bflex 2 regular 5.0 single-use bronchoscope returned to verathon for evaluation as it had been discarded at the facility along with the dlt.Since the device was not returned to verathon for evaluation, the exact cause could not be determined; however, it is likely that the cause of the reported issue is due to off-label use of the bronchoscope with a dlt.Photos provided by the customer showed the tip of the bronchoscope lodged inside the dlt with partial tearing of the bronchoscope's sheath.The bflex 2 bronchoscope - endotracheal tube compatibility" table found in the bflex 2 single-use bronchoscopes operations & maintenance manual (omm) lists the compatibility of the bflex 2 single-use bronchoscopes with certain endotracheal tubes, double-lumen tubes, and airway catheters.The double-lumen tube used during the procedure has not been validated by verathon for compatibility for use with the bflex 2 regular 5.0 single-use bronchoscope.Any usage of the bflex bronchoscope outside of what is listed in the omm is outside of verathon's released labeling.Following the reported event, the customer's verathon sales representatives provided refresher education with the customer.Trending analysis for the 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.

• 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: 22011695
• Report Number: 9615393-2025-00053
• Device Sequence Number: 7893323
• Product Code: EOQ
• UDI-Device Identifier: 00879123008565
• UDI-Public: (01)00879123008565(10)KS250303(11)250116(17)280117
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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): 05/13/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 0570-0423
• Device Catalogue Number: 0570-0449
• Device Lot Number: KS250303
• 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: 04/18/2025
• Initial Report FDA Received Date: 05/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/16/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown