MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE TITANIUM LOPRO T3 REUSABLE LARYNGOSCOPE; LARYNGOSCOPE, RIGID

Model Number	0574-0126
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device return is anticipated; however, at the time of this 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 titanium lopro t3 reusable laryngoscope, the image was distorted resulting in the user being unable to visualize the airway.The procedure was completed using a different laryngoscope.No delay in procedure or harm to the patient was reported.
Additional Manufacturer Narrative
B4, d8, d9, g3, g6, h2, h3, h6, h11.The customer's glidescope titanium lopro t3 reusable laryngoscope was returned to verathon for evaluation.A verathon technical service representative evaluated the returned device and was able to confirm the reported image issue.When connected to verathon's test equipment, the customer's lopro t3 produces a poor-quality image.Visual inspection identified the lens seal is damaged and signs of fluid ingress.The customer's lopro t3 failed verathon's device functionality testing.The glidescope video laryngoscopes operations and maintenance manual (omm) notes, "before every use, ensure that the instrument is operating correctly and has no sign of damage.Do not use this product if the device appears damaged." verathon followed up with the customer and restated the importance of checking the device before its use in a procedure.Upon completion of verathon's device evaluation, the customer's lopro t3 was scrapped with a replacement laryngoscope.Corrective action is not required at this time.Verathon will continue to monitor for trends.

• Brand Name: GLIDESCOPE TITANIUM LOPRO T3 REUSABLE 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: 22873803
• Report Number: 9615393-2025-00099
• Device Sequence Number: 5689501
• Product Code: CCW
• UDI-Device Identifier: 00879123003164
• UDI-Public: (01)00879123003164(11)240813
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2025

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: 0574-0126
• Device Catalogue Number: 0574-0147
• Device Lot Number: LA240610
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2025
• Supplement Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 08/22/2025
• Supplement Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2024
• 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