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	06/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported that during a patient procedure, using a glidescope go 2 monitor, the image produced appeared to get partially occluded by saliva as the user was advancing the endotrachial tube.It was reported that the screen flickered and turned completely white and the video signal was lost.The monitor was disconnected from the glidescope spectrum qc hyperangle s3 laryngoscope and reconnected but the image stayed white.No delay in the procedure, use of a backup device, or harm to the patient was reported.
Additional Manufacturer Narrative
A loaner monitor was provided to the customer and the reported glidescope go 2 monitor was returned to verathon for evaluation.A verathon technical service representative evaluated the returned monitor but was unable to confirm the reported failure.The monitor powered on normally and when connected to verathon's known, good, test equipment, it produced a normal image.The monitor was power-cycled ten (10) times with the system booting normally after each reboot and continued producing a normal image with verathon's test equipment.Each test imaging device was connected and disconnected twenty (20) times.No failures were observed and the monitor passed verathon's device functionality testing.The glidescope spectrum single-use qc hyperangle s3 laryngoscope used with the monitor during the reported event was not made available to verathon for evaluation.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: 19656756
• Report Number: 9615393-2024-00096
• Device Sequence Number: 6624460
• Product Code: CCW
• UDI-Device Identifier: 00879123008268
• UDI-Public: (01)00879123008268(11)231017
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 06/07/2024

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
• Date Returned to Manufacturer: 06/18/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2024
• Initial Report FDA Received Date: 07/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2023
• 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