MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE GO 2 MONITOR; LARYNGOSCOPE, RIGID

Model Number	0570-0427
Medical Device Problem Codes	No Display/Image (1183); Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device return is anticipated, however; at the time of the report the device has not been received by verathon.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
A customer reported that during a patient procedure, using a glidescope go 2 monitors, the image turned white, blocking the view of intubation.It was further reported that the connected blade was removed from the patient's mouth and the monitor was power cycled which they were then able to successfully intubate the patient.No delay in the procedure, use of a backup device, or harm to the patient was reported.
Additional Manufacturer Narrative
The customer's glidescope go 2 monitor was returned to verathon for evaluation.A verathon technical service representative evaluated the returned device but was unable to confirm the reported image issue.When connected to verathon's test equipment (including a single-use blade and a reusable video baton), the monitor produced a normal image.Three (3) recording tests were conducted, all of which passed exhibiting normal playback.The monitor was power cycled ten (10) times each with and without a test imaging device attached.No failures were observed and a normal image was produced when the test imaging device was attached.The monitor passed verathon's device functionality testing and confirmed to be within specification.The customer's monitor was also evaluated by verathon's engineering department for further investigation.Verathon's engineering assessment also could not replicate any image issues with the customer's monitor when tested with both single-use blades and a reusable video baton, plugging in both before and after powering on as well as rotating the hinge.The customer's laryngoscope that was connected to the monitor during the reported incident was not made available to verathon for evaluation.It is also unknown if the dynamic light control feature was enabled during use.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 2 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: 21304975
• Report Number: 9615393-2025-00016
• Device Sequence Number: 8848112
• Product Code: CCW
• UDI-Device Identifier: 00879123008268
• UDI-Public: (01)00879123008268(11)240603
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 01/09/2025

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: 0570-0427
• Device Catalogue Number: 0270-1107
• 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: 01/09/2025
• Supplement Date Received by Manufacturer: 02/28/2025
• Initial Report FDA Received Date: 02/04/2025
• Supplement Report FDA Received Date: 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2024
• 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