MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE BFLEX 2 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	05/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported glidescope bflex 2 regular 5.0 single-use bronchoscope was returned to verathon for evaluation.A verathon technical service representative (tsr) evaluated the returned bronchoscope but was unable to confirm the reported image freezing issue.When connected to known, good, test verathon equipment, the image remained clear through a full range of motion.Upon completion of the device evaluation by the tsr, the bronchoscope was sent to verathon's r&d engeering department for further evaluation and testing.When investigated by a verathon electrical engineer representative, the bronchoscope's video was initially functional.After removing the shell of the bronchoscope and applying stress to the ziff pcb, the video was intermittent.Upon closer inspection, the ziff pcb was found to be not glued to the connector pcb.The engineering representative confirmed that mechanical stress on the wire bundle did not result in a loss of video, therefore the failure was isolated to the ziff pcb component.The root cause of the reported image freezing issue was determined to be improper gluing of the ziff pcb during assembly resulting in damage to the video communication path.No corrective action is required at this time.Verathon will continue to monitor for trends.
Event or Problem Description
A customer reported that during a patient procedure, using a glidescope bflex 2 regular 5.0 single-use bronchoscope, the image on the connected monitor kept freezing.It was reported that the users unplugged the bronchoscope and cables and restarted the monitor but the issue continued to occur.The facility's verathon territory manager assisted the customer onsite with troubleshooting and was able to duplicate the reported issue with the subject bronchoscope used during the procedure but could not duplicate the issue when using a new glidescope bflex single-use bronchoscope.No delay in the procedure, use of a backup device, or harm to the patient was reported.

• Brand Name: GLIDESCOPE BFLEX 2 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: 17118347
• Report Number: 9615393-2023-00103
• Device Sequence Number: 20486084
• Product Code: EOQ
• UDI-Device Identifier: 10879123008562
• UDI-Public: 011087912300856210KS2311001123031517240317
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/19/2023

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: 03/17/2024
• Device Model Number: 0570-0423
• Device Catalogue Number: 0570-0449
• Device Lot Number: KS231100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2023
• Initial Report FDA Received Date: 06/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2023
• 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