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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The facility's glidescope spectrum single-use lopro s4 blades are not available to be returned to verathon for evaluation, therefore the cause could not be determined.The facility reported they were unsure whether the issue is related to the glidescope core 15-inch monitor or the lopro blades but that their biomedical engineering department was going to evaluate the entire system.Verathon has made multiple follow-up attempts to confirm additional information including any results from the facility's troubleshooting of the glidescope system.To date, no response has been received.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 blades 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.Should additional information become available, a supplemental report will be submitted in accordance with 21 cfr 803.56.Corrective action is not required at this time.Verathon will continue to monitor for trends.
Event or Problem Description
A facility reported the glidescope spectrum single-use lopro s4 blade was appropriately checked prior to intubation and confirmed to be functioning properly.However, immediately upon insertion into the patient's mouth, the light on the blade turned off.When the blade was removed, the light came back on.It was reported that this occurred three times in which the blade had to be changed in order for the device to function properly, requiring multiple intubation attempts due to the reported malfunction.No harm to the patient was reported.The date of event remains unknown despite multiple follow-up attempts made by verathon.

• 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: 24651682
• Report Number: 9615393-2026-00033
• Device Sequence Number: 18591204
• Product Code: CCW
• UDI-Device Identifier: 00879123006233
• UDI-Public: (01)00879123006233(10)GU1020024(11)250805(17)280805
• 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,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/19/2026

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: 0574-0195
• Device Catalogue Number: 0270-0939
• Device Lot Number: GU1020024
• 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: 02/19/2026
• Initial Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/05/2025
• 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