MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE SPECTRUM SINGLE-USE LOPRO S3 LARYNGOSCOPE; LARYNGOSCOPE, RIGID

Model Number	0574-0194
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	12/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject glidescope spectrum single-use lopro s3 laryngoscope is not available to be returned to verathon for evaluation, therefore the cause could not be determined.Review of complaint history for the reported lot number did not identify any previous complaints reported to verathon.Trending analysis for glidescope spectrum single-use lopro laryngoscopes does not identify any trends exceeding acceptable limits.Verathon confirmed that the risk associated with the hazardous scenario has been adequately captured and characterized per the system risk assessment.Corrective action is not required at this time.Verathon will continue to monitor for trends.
Event or Problem Description
A facility reported that the light on a glidescope spectrum single-use lopro s3 laryngoscope was not functional when used to intubate a patient.They reported when the blade was in the room, users were able to visualize the surroundings; however, once inserted in the patient's mouth, the image was completely dark.The procedure was completed using a backup glidescope system.No delay in procedure or harm to the patient was reported.

• Brand Name: GLIDESCOPE SPECTRUM SINGLE-USE LOPRO S3 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: 24060181
• Report Number: 9615393-2026-00004
• Device Sequence Number: 13117102
• Product Code: CCW
• UDI-Device Identifier: 00879123006226
• UDI-Public: (01)00879123006226(10)GT1017037(11)250708(17)280708
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,User Facility,Distributor
• Initial Reporter Occupation: 505
• Type of Report: Initial
• Report Date (Section B): 01/13/2026

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: 0574-0194
• Device Catalogue Number: 0270-0938
• Device Lot Number: GT1017037
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2026
• Initial Report FDA Received Date: 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/08/2025
• 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