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

Model Number	0570-0424
Medical Device Problem Codes	Erratic or Intermittent Display (1182); Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported bflex 2 large 5.8 single-use bronchoscope was returned to verathon for evaluation.A verathon technical service representative evaluated the returned device but was unable to confirm the reported image issue.When using the bflex with verathon's test equipment, the bflex produced a normal image.Furthermore, the bflex passed visual inspection and the articulation was normal.Neither the monitor nor the cable used with the bflex were made available to verathon for evaluation.Upon completion of verathon's device evaluation, the bronchoscope was sent to verathon's engineering department for further investigation.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 while using a bflex 2 large 5.8 single-use bronchoscope during a bedside bronchoscopy, the image on the connected glidescope core monitor froze four separate times.The bronchoscope was replaced and the procedure proceeded without incident.No delay in procedure or harm to the patient was reported.

• 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 V5C5A 9; CA V5C5A9
• Manufacturer (Section G): VERATHON MEDICAL ULC; 2227 douglas road; burnaby, british columbia V5C5A 9; CA V5C5A9
• Manufacturer Contact: corey kasbohm ; 20001 n creek pkwy; bothell, WA 98011-8218 ; 4256295760
• MDR Report Key: 21537679
• Report Number: 9615393-2025-00024
• Device Sequence Number: 12696673
• Product Code: EOQ
• UDI-Device Identifier: 00879123008572
• UDI-Public: 00879123008572
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/17/2025

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 Model Number: 0570-0424
• Device Catalogue Number: 0570-0450
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2025
• Initial Report FDA Received Date: 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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