MAUDE Adverse Event Report: VERATHON MEDICAL ULC BFLEX 2 LARGE 5.8 SINGLE-USE BRONCHOSCOPE

Model Number	0570-0424
Medical Device Problem Codes	Degraded (1153); Flaked (1246); Material Frayed (1262); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The bflex 2 large 5.8 single-use bronchoscope used during the reported event was returned to verathon for evaluation along with other samples from the same lot.Visual inspection confirmed the reported sheath damage at the bronchoscope's distal end.The device samples were then provided to verathon's engineering department for further testing and evaluation.During verathon's device testing, it became known from the facility that their emergency department has ultraviolet (uv) cleaning lights installed in their rooms which suggests a possibility that the bronchoscope may have been exposed to uv light prior to its use in the procedure.Review of complaint history for similar events found a prior investigation that verathon conducted on samples of the first 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.Verathon continues to investigate the reported event and will submit a supplemental report in accordance with 21 cfr 803.56 should additional information become available.
Event or Problem Description
A customer reported a bflex 2 large 5.8 single-use bronchoscope was advanced through a 7.5 shiley endotracheal (et) tube after being sprayed with silko spray.While advanced, no resistance was felt.The bronchoscope was removed from the et tube to wipe off a piece of aspirated food from the end of the bronchoscope.No resistance was felt while removing the scope from the et tube.Once removed, it was identified that the outer sheath near the tip of the bronchoscope was fraying and coming loose.A new bflex 2 regular 5.0 single-use bronchoscope was used to complete the procedure.It was reported that no debris was discovered in the airway, no medical intervention was required, and there was no adverse outcome for the patient.Following the customer's notification to verathon of this event, verathon received the facility's medsun report number (b)(4) for this event on march 17, 2025, which indicated that the bronchoscopes were used for a bronchoscopy to re-evaluate the patient's airway for residual food contents.
Additional Manufacturer Narrative
**b4, g6, h2, h10 updates only** this is a supplemental report solely to provide the related user facility medsun report number in the corresponding field, h10 - related report number.

• Brand Name: BFLEX 2 LARGE 5.8 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: 21755445
• Report Number: 9615393-2025-00035
• Device Sequence Number: 8220296
• Product Code: EOQ
• UDI-Device Identifier: 00879123008572
• UDI-Public: (01)00879123008572(10)KT235000(11)231211(17)251215
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2025

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 Expiration Date: 12/15/2025
• Device Model Number: 0570-0424
• Device Catalogue Number: 0570-0450
• Device Lot Number: KT235000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/02/2025
• Supplement Report FDA Received Date: 04/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2023
• 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: Other
• Patient Age: 84 YR
• Patient Sex: Male
• Patient Weight: 27 KG