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

Model Number	0574-0188
Medical Device Problem Codes	No Display/Image (1183); Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported upon laryngoscopy, it was noted that the camera on the glidescope spectrum single-use directview mac s4 laryngoscope was working; however, there was no light source resulting in a black/dark screen with no visible anatomy when the blade was inserted into the patient.The intubation attempt was temporarily abandoned as users obtained a secondary glidescope unit while bag-mask-ventilating the patient.The intubation was successfully completed using a reusable glidescope blade.No delay in procedure or harm to the patient was reported.The date of event is unknown.
Additional Manufacturer Narrative
The customer's glidescope spectrum single-use directview mac s4 laryngoscope was not returned to verathon, therefore the cause could not be determined.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 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 SPECTRUM SINGLE-USE DIRECTVIEW MAC 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: 24192369
• Report Number: 9615393-2026-00006
• Device Sequence Number: 7976041
• Product Code: CCW
• UDI-Device Identifier: 00879123006257
• UDI-Public: (01)00879123006257(10)GW1011690(11)241104(17)271104
• 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): 01/27/2026

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: 0574-0188
• Device Catalogue Number: 0270-0933
• Device Lot Number: GW1011690
• 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: 04/28/2025
• Initial Report FDA Received Date: 01/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/04/2024
• 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