MAUDE Adverse Event Report: VERATHON MEDICAL ULC BFLEX2 REGULAR 5.0 SINGLE-USE BRONCHOSCOPE; BRONCHOSCOPE (FLEXIBLE OR RIGID)

Model Number	0570-0423
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	10/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device return is anticipated, however; at the time of the report the device has not been received by verathon.Verathon continues to investigate the reported event and a supplemental report will be submitted in accordance with 21 cfr 803.56 when additional information becomes available.
Event or Problem Description
A customer reported while using a bflex2 regular 5.0 single-use bronchoscope during a patient procedure, the image blacked out.A second bronchoscope from the same package was obtained but the image was reported to flicker and then it also blacked in and out.The procedure was still able to be completed using the second bronchoscope.No delay in procedure or harm to the patient was reported.Following the reported event, the customer's verathon territory manager evaluated the glidescope system at the user facility and reported isolating the issue to the bronchoscope initially used.The second bronchoscope used to finish the procedure had already been discarded by the facility.

• Brand Name: BFLEX2 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 98011-8218 ; 4256295760
• MDR Report Key: 20747610
• Report Number: 9615393-2024-00147
• Device Sequence Number: 8648915
• Product Code: EOQ
• UDI-Device Identifier: 00879123008565
• UDI-Public: (01)00879123008565(10)KS234900(11)231204(17)251208
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/23/2024

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: 12/08/2025
• Device Model Number: 0570-0423
• Device Catalogue Number: 0570-0449
• Device Lot Number: KS234900
• 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: 10/23/2024
• Initial Report FDA Received Date: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/04/2023
• 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