MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE GO MONITOR; LARYNGOSCOPE, RIGID

Model Number	0570-0366
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	07/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been received by verathon; however, the device return is anticipated.Verathon continues to investigate the reported event and a supplemental report will be submitted in accordance with 21 cfr 803.56 when additional information becomes available.
Event or Problem Description
While trying to intubate a patient with a glidescope go monitor, a customer reported the screen turned green and black when inserting the connected blade inside the patient's mouth.It was further reported by the customer, that the blades easily disconnected from the monitor; therefore, the unsecure connections resulted in the screen turning green and black.No delay in procedure, use of a backup device, or harm to the patient was reported.
Additional Manufacturer Narrative
B4, d4, d8, d9, g3, g6, h2, h3, h6, h11.The customer's glidescope go monitor was returned to verathon for evaluation.A verathon technical service representative (tsr) evaluated the returned device but was unable to confirm the reported issue.When connected to verathon's test equipment, the system produced a normal image.The tsr tried wiggling the connection, detaching and reattaching the test devices, manipulating the monitor arm up and down, and power-cycling the monitor with test devices attached.No imaging issues were observed using test devices.The customer's monitor passed verathon's device functionality testing and confirmed to be within specification.The laryngoscope used with the monitor during the reported event was not made available to verathon for evaluation as it had been thrown away at the facility.Upon completion of verathon's device evaluation, the monitor was returned to the customer.No further investigation is required at this time.Verathon will continue to monitor for trends.

• Brand Name: GLIDESCOPE GO 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: 22654131
• Report Number: 9615393-2025-00079
• Device Sequence Number: 15657496
• Product Code: CCW
• UDI-Device Identifier: 00879123006189
• UDI-Public: (01)00879123006189(11)190201
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2025

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: 0570-0366
• Device Catalogue Number: 0570-0368
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2025
• Supplement Date Received by Manufacturer: 08/04/2025
• Initial Report FDA Received Date: 07/29/2025
• Supplement Report FDA Received Date: 08/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2019
• 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