MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE CORE 15-INCH FHD MONITOR; LARYNGOSCOPE, RIGID

Model Number	0570-0437
Medical Device Problem Codes	Erratic or Intermittent Display (1182); Display or Visual Feedback Problem (1184); Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer's glidescope core 15-inch fhd monitor was returned to verathon for evaluation along with the glidescope core 2m quickconnect cable, glidescope core smart cable, and bflex 2 large 5.8 single-use bronchoscope used during the reported procedure.A verathon technical service representative (tsr) evaluated the returned devices but was unable to confirm the reported image issue.When used with verathon's test equipment, the tsr attempted to adjust and wiggle connections, detaching and reattaching components, and power-cycling the monitor while the devices were connected.The tsr utilized both the a and b ports of the monitor with each device and no imaging problems were detected.The monitor passed verathon's device functionality testing and was confirmed to be within specification.Next, the customer's cables were tested and functioned as expected when used with the test devices and the customer's monitor.No issues were identified with the customer's cables.Next, the customer's bflex 2 bronchoscope was evaluated and no imaging problems were detected while used with a test monitor and cable.Upon completion of verathon's device evaluation, the monitor and cables were returned to the customer and the bflex 2 bronchoscope was sent to verathon's engineering department for further evaluation.Should additional information become available, a supplemental report will be submitted by verathon in accordance with 21 cfr 803.56.Corrective action is not required at this time.Verathon will continue to monitor trends.
Event or Problem Description
A customer reported while using a glidescope core 15-inch fhd monitor during a bedside bronchoscopy, the monitor experienced a glitch, resulting in the appearance of green and purple lines and a loss of video.No delay in procedure, use of a backup device, or harm to the patient was reported.

• Brand Name: GLIDESCOPE CORE 15-INCH FHD MONITOR
• Common Device Name: LARYNGOSCOPE, 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: 22509363
• Report Number: 9615393-2025-00076
• Device Sequence Number: 18467391
• Product Code: CCW
• UDI-Device Identifier: 00879123008596
• UDI-Public: (01)00879123008596(11)240725
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 07/15/2025

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: 0570-0437
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown