MAUDE Adverse Event Report: Verathon Medical ULC BFlex 2 Regular 5.0 Single-Use Bronchoscope; BRONCHOSCOPE (FLEXIBLE OR RIGID)

Model Number	0570-0423
Medical Device Problem Codes	Degraded (1153); Material Disintegration (1177); Flaked (1246)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A customer reported while using bflex 2 regular 5.0 and bflex 2 large 5.8 single-use bronchoscopes during a patient procedure in the intensive care unit (icu), part of their plastic casing started disintegrating and ended up in the patient's airway.An additional procedure via bedside bronchoalveolar lavage (bal) was required to recover the remainder of the particles that were left in the patient.
Additional Manufacturer Narrative
The subject bflex 2 regular 5.0 and bflex 2 large 5.8 single-use bronchoscopes were not returned to verathon for evaluation; however, additional communication with the facility and their verathon territory manager determined that the bronchoscopes were likely exposed to ultraviolet (uv) light prior to use in the procedure.The facility reported that they utilize uv light as part of their cleaning process by integrating uv disinfectant that activates when rooms are not in use.The facility was unable to confirm how long the bronchoscopes had been in the room prior to being used but they had been hanging on the back of the glidescope core system prior to the case.Photos were provided showing the distal end of the bronchoscope sheaths that were damaged, visually consistent with uv-related material degradation.The bflex 2 single-use bronchoscope operations & maintenance manual contains a caution stating, "do not store endoscope pouches in direct sunlight or expose them to ultraviolet (uv) light.Such exposure can weaken the materials in the endoscope or its pouch." verathon reiterated to the facility the importance of not exposing the devices to uv light.Review of complaint history for the reported lot numbers ks251303 and kt244203 did not identify any previous complaints reported to verathon.Trending analysis for bflex 2 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.Should additional information become available, a supplemental report will be submitted in accordance with 21 cfr 803.56.Corrective action is not required at this time.Verathon will continue to monitor for trends.Reference the attached corresponding report containing the device information for the subject bflex 2 large 5.8 single-use bronchoscope involved in the reported event.

• Brand Name: BFlex 2 Regular 5.0 Single-Use Bronchoscope
• Common Device Name: BRONCHOSCOPE (FLEXIBLE OR RIGID)
• 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--821 ; +1(425)629-5760
• MDR Report Key: 50062269
• Report Number: 9615393-2026-00108
• Device Sequence Number: 13428321
• Product Code: EOQ
• UDI-Device Identifier: 00879123008565
• UDI-Public: (01)00879123008565(10)KS251303(11)250327(17)280328
• 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): 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): 07/28/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 0570-0423
• Device Catalogue Number: 0570-0449
• Device Lot Number: KS251303
• 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: 07/02/2026
• Initial Report FDA Received Date: 07/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/27/2025
• 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