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

Model Number	0570-0437
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported glidescope core 15-inch fhd monitor was returned to verathon for evaluation.A verathon technical service representative (tsr) evaluated the returned glidescope core 15-inch fhd monitor.The tsr confirmed the issue by using verathon's device functionality test equipment.During testing, the tsr was able to reproduce the static image issue on two occasions.Based on these findings, the tsr replaced the monitor's embedded displayport (edp) printed circuit board assembly (pcba) to address the intermittent display malfunction.The customer's glidescope core 2m quickconnect cable was not made available to verathon for evaluation.Upon completion of the evaulation, the glidescope core 15-inch fhd monitor was returned to the customer.No further investigation is required at this time.Corrective action is not required at this time, and verathon will continue to monitor for trends.
Event or Problem Description
A customer reported that during a bronchoscopy procedure, using a verathon glidescope core 15-inch fhd monitor, the screen became glitchy with lines appearing across the display obscuring the physician's view of the patient's airway.No harm to the patient was reported, but there was a temporary disruption to the procedure while attempting to troubleshoot and obtain a second unit.

• 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: 22720785
• Report Number: 9615393-2025-00082
• Device Sequence Number: 12962985
• Product Code: CCW
• UDI-Device Identifier: 00879123008596
• UDI-Public: (01)00879123008596(11)240725
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/05/2025

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 Catalogue Number: 0270-1022
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2025
• Initial Report FDA Received Date: 08/05/2025
• 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