MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE GO; VIDEO LARYNGOSCOPE

Model Number	0570-0368
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported that during multiple uses of a glidescope go video laryngoscope, the monitor intermittently displayed no image or a black screen.The issue was reported to have occurred during two separate emergency calls over the past month.The customer indicated that during the second event, the patient passed away.However, the customer could not confirm whether the reported image issue contributed to the outcome.The suspect device was returned to verathon for evaluation.
Additional Manufacturer Narrative
The glidescope go video monitor was returned to verathon for evaluation.No damage or visual anomalies were observed on the device housing or connector.The monitor was tested using three different test batons, and all functions performed within specification.The reported black screen issue could not be duplicated.A review of complaint and service history for serial number (b)(6) did not identify any similar events.No trends exceeding acceptable thresholds were found for the glidescope go product line.Verathon confirmed that the potential risk associated with this behavior is adequately characterized in the existing system risk assessment.No corrective action is required at this time.Verathon will continue to monitor for trends.

• Brand Name: GLIDESCOPE GO
• Common Device Name: VIDEO LARYNGOSCOPE
• Manufacturer (Section D): VERATHON MEDICAL ULC; 2227 douglas road; burnaby, british columbia V5C 5 A9; CA V5C 5A9
• Manufacturer (Section G): VERATHON MEDICAL; 20001 n creek pkwy; bothell WA 98011 8218
• Manufacturer Contact: corey kasbohm ; 20001 n creek pkwy; bothell, WA 98011-8218 ; 4256295760
• MDR Report Key: 22720786
• Report Number: 9615393-2025-00090
• Device Sequence Number: 8805113
• Product Code: CCW
• UDI-Device Identifier: 00879123006189
• UDI-Public: (01)00879123006189(11)230131
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 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: 0570-0368
• Device Catalogue Number: 0570-0368
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2025
• 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