MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE SPECTRUM SINGLE-USE LOPRO S4 LARYNGOSCOPE; LARYNGOSCOPE, RIGID

Model Number	0574-0195
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	01/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported glidescope spectrum single-use lopro s4 laryngoscope was returned to verathon for evaluation.A verathon technical service representative (tsr) evaluated the returned device but was unable to confirm the reported image issue.When connected to verathon's test equipment, the system produced a normal image.The tsr tried detaching and reattaching the lopro s4, wiggling the connection, and adjusting the light level on the test monitor.Neither the light nor the image were observed cutting out.The lopro s4 passed verathon's device functionality testing and confirmed to be within specification.Neither the monitor nor the cable used with the subject lopro s4 during the reported incident were made available to verathon for evaluation.Upon completion of verathon's device evaluation, the lopro s4 was scrapped due to being a single-use device.No further investigation is required at this time.Verathon will continue to monitor for trends.
Event or Problem Description
A customer reported while using a glidescope spectrum single-use lopro s4 laryngoscope during an intubation, the light and picture went out.The laryngoscope was removed and replaced with another lopro s4 and the procedure proceeded without incident.No delay in the procedure or harm to the patient was reported.

• Brand Name: GLIDESCOPE SPECTRUM SINGLE-USE LOPRO S4 LARYNGOSCOPE
• 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: 21252946
• Report Number: 9615393-2025-00011
• Device Sequence Number: 8206288
• Product Code: CCW
• UDI-Device Identifier: 00879123006233
• UDI-Public: (01)00879123006233(10)GU1008180(11)240618(17)270618
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 01/07/2025

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: 0574-0195
• Device Catalogue Number: 0270-0939
• Device Lot Number: GU1008180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2025
• Initial Report FDA Received Date: 01/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown