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	Material Separation (1562); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject bflex 2 large 5.8 single-use bronchoscope was not retained by the facility, and therefore not available to be evaluated by verathon.Photos were provided showing the sheath near the distal tip of the bronchoscope was torn and partially missing.The "bflex 2 bronchoscope - endotracheal tube compatibility" table found in the operations & maintenance manual (omm) lists the compatibility of the bflex 2 single-use bronchoscopes with certain endotracheal tubes, double-lumen tubes, and airway catheters.While the endotracheal tube used during the procedure has been validated by verathon for compatibility with the bflex 2 large 5.8 single-use bronchoscope, verathon has not validated the bodai adapter.Furthermore, the omm notes, "there is no guarantee that instruments selected solely using these instrument dimensions will be compatible in combination." follow-up information from the facility received by verathon's clinical specialist reported the physician involved in the reported incident may be new to performing bronchoscopies and it is unknown if the bronchoscope was articulated upon removal from the ett.The omm contains a warning which states, "before withdrawing the bronchoscope, place the distal tip into a straight, neutral position.While withdrawing, do not touch the control lever.Any bend in the distal tip may result in patient injury." it is possible that the distal tip not being in a straight, neutral position during withdrawal may have caused or contributed to the reported sheath tear.Review of complaint history for the reported lot number "kt241701" 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.Corrective action is not required at this time.Verathon will continue to monitor for trends.
Event or Problem Description
A customer reported to their verathon clinical specialist that the sheath of a bflex 2 large 5.8 single-use bronchoscope tore during a bronchoscopy procedure.It was reported that the patient was already intubated with a 7.5 shiley evac endotracheal tube (ett).A sontek suction-safe y bodai swivel adapter was placed on top of the ett and the bronchoscope passed through it to clean the patient out while also ventilating.After removal of the bronchoscope, the users realized there was a significant tear at the tip of the bronchoscope, exposing the internal components.No delay in procedure, use of a backup, or harm to the patient was reported.Follow-up information received by the verathon clinical specialist reported the bronchoscope was believed to have torn upon withdrawl from the ett / bodai adapter.A ct scan was performed which confirmed no parts of the bronchoscope were identified in the patient's lungs.

• 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: 24810828
• Report Number: 9615393-2026-00043
• Device Sequence Number: 18627991
• Product Code: EOQ
• UDI-Device Identifier: 00879123008572
• UDI-Public: (01)00879123008572(10)KT241701(11)240423(17)260426
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 04/07/2026

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: 04/26/2026
• Device Model Number: 0570-0424
• Device Catalogue Number: 0570-0450
• Device Lot Number: KT241701
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/23/2024
• 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