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

Model Number	0570-0427
Medical Device Problem Codes	Erratic or Intermittent Display (1182); Display or Visual Feedback Problem (1184); Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A loaner monitor was provided to the customer and the customer's 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 image issue.When connected to verathon's known, good test laryngoscope and video baton, evaluating each through thorough motion with the monitor, no whiting out or other image issues were observed.The customer's glidescope go 2 monitor passed verathon's device functionality testing.The glidescope spectrum single-use qc hyperangle s4 laryngoscope used with the monitor during the reported incident was not made available to verathon for evaluation.Follow-up communication from the customer also indicated that a video file would be provided showing the reported white-out conditions experienced.To date, verathon has not received the mentioned video file.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.
Event or Problem Description
A customer reported that during an emergency care procedure, using a glidescope go 2 monitor, the screen experienced a "white-out" condition multiple times when using with a glidescope spectrum single-use qc hyperangle s4 laryngoscope.Follow-up communication from the customer reported that it resulted in a complete loss of airway during the white-out but the patient was successfully intubated with a backup device shortly after the initial screen issues.No delay in the procedure or harm to the patient was reported.

• 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: 19606536
• Report Number: 9615393-2024-00092
• Device Sequence Number: 17725910
• Product Code: CCW
• UDI-Device Identifier: 00879123008268
• UDI-Public: 0100879123008268
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 05/28/2024

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: 06/12/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2024
• Initial Report FDA Received Date: 06/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2024
• 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