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	07/21/2025
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 facility reported that during an endotracheal intubation, using a glidescope titanium lopro t3 reusable laryngoscope, the image was so poor and fuzzy/blurry that the user needed to come back out of the patient's mouth to apply alcohol to the lens in order to improve the image.It was reported that it was not an emergency situation and the patient was stable.No delay in procedure, use of a backup device, or harm to the patient was reported.
Additional Manufacturer Narrative
The customer declined the option to have their glidescope titanium lopro t3 reusable laryngoscope returned to verathon for evaluation, therefore the cause could not be determined.Follow-up information from the facility indicated they sterilize their lopro t3 between uses via asp hydrogen peroxide gas plasma.Verathon followed up to confirm how many reprocessing cycles the device has undergone as well as confirmation if the device was inspected for damage.To date, no response has been received.The glidescope and gliderite products reprocessing manual indicates not to exceed 300 sterilization cycles under the conditions used at the facility.Furthermore, the glidescope video larygnoscopes operations & maintenance manual states, "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.".Review of complaint history for the reported serial number "(b)(6)" did not identify any previous complaints reported to verathon.Trending analysis for the glidescope titanium lopro reusable 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.

• 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: 22841687
• Report Number: 9615393-2025-00092
• Device Sequence Number: 18536916
• Product Code: CCW
• UDI-Device Identifier: 00879123003164
• UDI-Public: (01)00879123003164(11)230727
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2025

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: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2025
• Supplement Date Received by Manufacturer: 09/30/2025
• Initial Report FDA Received Date: 08/19/2025
• Supplement Report FDA Received Date: 09/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/27/2023
• 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