MAUDE Adverse Event Report: VERATHON MEDICAL ULC BFLEX 2 LARGE 5.8 SINGLE-USE BRONCHOSCOPE; BRONCHOSCOPE (FLEXIBLE OR RIGID)

Model Number	0570-0424
Medical Device Problem Codes	Flaked (1246); Material Frayed (1262)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer declined to return the subject bflex 2 large 5.8 single-use bronchoscope to verathon for evaluation as it is being retained by the facility.A photo was provided to verathon which shows the distal end of the bronchoscope's outer sheath deteriorated/frayed.Verathon has made multiple follow-up attempts to the customer for additional information regarding the event including patient status and device use-related information in attempt to investigate potential cause.To date, no further information has been made available, however, the facility reported they continue conducting their own internal review of the event.Review of complaint history for the reported lot number "kt251404" did not identify any previous complaints reported to verathon.Review of the device history record for the reported lot number found no anomalies or deviations that could have contributed to the reported event.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.
Event or Problem Description
A customer reported that a patient was intubated using a bflex 2 large 5.8 single-use bronchoscope with a 7.5 mm endotrachial tube.After the intubation, the bronchoscope was removed from the patient and the white coating on the tip of the bronchoscope appeared to have frayed off.A subsequent bronchoscopy was then performed on the patient to remove the pieces that fell off in the lungs.No harm to the patient was reported.

• Brand Name: BFLEX 2 LARGE 5.8 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 98011-8218 ; 4256295760
• MDR Report Key: 23467272
• Report Number: 9615393-2025-00123
• Device Sequence Number: 21319624
• Product Code: EOQ
• UDI-Device Identifier: 00879123008572
• UDI-Public: (01)00879123008572(10)KT251404(11)250404(17)280404
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 11/04/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 0570-0424
• Device Catalogue Number: 0570-0450
• Device Lot Number: KT251404
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2025
• Initial Report FDA Received Date: 11/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/04/2002
• 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