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	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	01/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported glidescope bflex 2 large 5.8 single-use bronchoscope was returned to verathon for evaluation.A verathon technical service representative (tsr) evaluated the returned device but was unable to confirm the reported image issue.When using the bflex with verathon's test equipment, the tsr tried detaching and reattaching the bflex, wiggling the connection, and manipulating the flexible tube.However, no image loss or other imaging issues were observed.The bflex passed verathon's device functionality testing and was confirmed to be operating according to specification.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 scrapped due to being single-use device.No further investigation is 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, the image on the connected glidescope core 15-inch fhd monitor disappeared in the middle of intubation.The bronchoscope was replaced with a brief delay and the procedure proceeded without incident.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: 21252945
• Report Number: 9615393-2025-00014
• Device Sequence Number: 8206287
• Product Code: EOQ
• UDI-Device Identifier: 00879123008572
• UDI-Public: (01)00879123008572(10)KT243100(11)240729(17)270802
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/06/2025

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: KT243100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2025
• Initial Report FDA Received Date: 01/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2024
• 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