MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE SPECTRUM SINGLE-USE QC MAC S4; LARYNGOSCOPE, RIGID

Model Number	0574-0228
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	02/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer declined the option to have their glidescope system returned to verathon for evaluation, therefore the cause could not be determined.Follow-up information received from the customer reported that the issue was resolved when the blade was changed and the system continues to be in clinicial use with no further reported issues.Review of complaint history for the reported monitor did not identify any previous complaints reported to verathon.Review of complaint history for the subject blade was unable to be performed due to no lot number being provided.Trending analysis for glidescope spectrum qc 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.Corrective action is not required at this time.Verathon will continue to monitor for trends.
Event or Problem Description
A customer reported while using a glidescope core 15-inch fhd monitor during a controlled intubation in the intensive care unit (icu), the image on the screen exhibited a near whiteout from the connected glidescope spectrum single-use qc mac s4 blade.The procedure was completed using a different spectrum qc mac s4 blade which was made available in an unspecified amount of time.The customer noted that a laryngeal mask airway (lma) device was employed to keep the airway open while the blade was being replaced.No delay in procedure or harm to the patient was reported.

• Brand Name: GLIDESCOPE SPECTRUM SINGLE-USE QC MAC S4
• Common Device Name: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): VERATHON MEDICAL ULC; 2227 douglas road; burnaby, british columbia V5C5A 9; CA V5C5A9
• Manufacturer (Section G): VERATHON MEDICAL ULC; 2227 douglas road; burnaby, british columbia V5C5A 9; CA V5C5A9
• Manufacturer Contact: corey kasbohm ; 20001 n creek pkwy; bothell, WA 98011-8218 ; 4256295760
• MDR Report Key: 24746118
• Report Number: 9615393-2026-00039
• Device Sequence Number: 9166089
• Product Code: CCW
• UDI-Device Identifier: 00879123007957
• UDI-Public: 00879123007957
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/31/2026

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: 0574-0228
• Device Catalogue Number: 0270-1086
• Device Lot Number: UNKNOWN
• 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: 03/02/2026
• Initial Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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