MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE CORE 10-INCH MONITOR; LARYNGOSCOPE, RIGID

Model Number	0570-0376
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	09/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported while using a glidescope core 10-inch monitor, the image on the display kept going on and off while intubating.The facility's biomedical engineering department reported being unable to duplicate the issue during their troubleshooting following the reported incident.The procedure was completed using a different glidescope system which was made available in an unspecified amount of time.No delay in the procedure or harm to the patient was reported.
Additional Manufacturer Narrative
The customer declined the option to have their glidescope core 10-inch monitor returned to verathon for evaluation; therefore, the cause could not be determined.Following the initial contact from the customer, they were provided the current software version for updating their glidescope core 10-inch monitor.Verathon made multiple follow-up attempts to confirm if the updated software resolved the issues experienced.To date, no response has been received.Review of complaint history for the reported monitor serial number "(b)(6)" did not identify any previous complaints reported to verathon.Trending analysis for glidescope core monitors does not identify any trends exceeding acceptable limits.Verathon confirmed that the risk associated with the hazardous scenario has been adequately captured and characterized per the system risk assessment.Corrective action is not required at this time.Verathon will continue to monitor for trends.

• Brand Name: GLIDESCOPE CORE 10-INCH 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: 23349369
• Report Number: 9615393-2025-00117
• Device Sequence Number: 9470920
• Product Code: CCW
• UDI-Device Identifier: 00879123006509
• UDI-Public: (01)00879123006509(11)210401
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 10/21/2025

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: 0570-0376
• Device Catalogue Number: 0270-0996
• Device Lot Number: N/A
• 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: 09/26/2025
• Initial Report FDA Received Date: 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2021
• 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