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)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported glidescope core 15-inch fhd monitor was returned to verathon for evaluation along with the glidescope core 2m quickconnect cable used during the reported event.A verathon technical service representative evaluated the returned devices and was able to confirm the reported image issue.When connecting the reported monitor to verathon's test equipment, the display intermittently loses the entire image and no user interface is visible.The issue was isolated to a faulty printed circuit board assembly (pcba).The monitor failed verathon's device functionality testing.Next, when evaluating the returned cable with verathon's test equipment, it passed both visual inspection and device functionality testing.Upon completion of verathon's device evaluation, the monitor's pcba was replaced and both the monitor and cable were returned to the customer.Corrective action is not required at this time.Verathon will continue to monitor for trends.
Event or Problem Description
A customer reported while using a glidescope core 15-inch fhd monitor during a bronchoscopy, the image went dark.The issue was fixed by unplugging the bronchoscope and then it worked.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: 22091910
• Report Number: 9615393-2025-00058
• Device Sequence Number: 20800030
• Product Code: CCW
• UDI-Device Identifier: 00879123008596
• UDI-Public: (01)00879123008596(11)240514
• 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): 05/27/2025

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: 05/07/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2025
• Initial Report FDA Received Date: 05/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2024
• 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