MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE TITANIUM LOPRO T4 REUSABLE LARYNGOSCOPE; LARYNGOSCOPE, RIGID

Model Number	0574-0127
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	01/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The glidescope titanium lopro t4 reusable laryngoscope was returned to verathon for evalaution.A verathon technical service representative evaluated the returned device and was able to confirm the reported image issue.Upon visual inspection, the front camera lens was found to be melted.When connected to verathon's test equipment, it produced poor image quality.The customer's glidescope titanium lopro t4 failed verathon's device functionality testing.Following verathon's device evaluation, the customer was notified about verathon's evaluation findings including the lens damage identified.The melted front lens was determined to be likely caused by exposure to excess heat during reprocessing.In accordance with verathon's glidescope products reprocessing manual, the titanium blades are not validated for autoclave sterilization.The reprocessing manual contains a caution stating: "do not expose any system component to temperatures above 60°c (140°f), and do not use autoclaves or other heat sterilization systems, except as described in this manual.Exposure to excess heat causes permanent device damage." the t4 is also direct marked stating, "do not autoclave" on the handle.Furthermore, following reprocessing, the reprocessing manual states to examine the component to make sure it is not damaged and do not use the component if any damaged is identified.The glidescope video laryngoscopes operations and maintenance manual (omm) also 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.
Event or Problem Description
A customer reported that during an intubation, the image from the glidescope titanium lopro t4 reusable laryngoscope was dark and did not allow the anesthetist to complete the intubation of the patient.No use of a backup device, delay in procedure, or harm to the patient was reported.

• Brand Name: GLIDESCOPE TITANIUM LOPRO T4 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: 24253160
• Report Number: 9615393-2026-00010
• Device Sequence Number: 15542586
• Product Code: CCW
• UDI-Device Identifier: 00879123003171
• UDI-Public: (01)00879123003171(11)250218
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,Distributor
• Initial Reporter Occupation: 505
• Type of Report: Initial
• Report Date (Section B): 02/03/2026

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: 0574-0127
• Device Catalogue Number: 0574-0148
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2026
• Initial Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2025
• 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