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

Model Number	0574-0228
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)
Date of Event	11/20/2025
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 remains in contact with the canadian distributor and continues to investigate the reported event.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 the glidescope spectrum single-use qc mac s4 laryngoscope caused the screen on the glidescope video laryngoscopy system to freeze during the intubation of a patient.The system was powered down and restarted again, only to have the screen freeze once more.The mac s4 was trialled on other glidescope systems and found to cause the screen on those devices to freeze as well.The patient was intubated successfully with direct laryngoscopy and no harm to the patient was reported.
Additional Manufacturer Narrative
B4, d8, d9, e1, e2, e3, g2, g3, g6, h2, h3, h6, h11 the glidescope spectrum single-use qc mac s4 was returned to verathon for evaluation.A verathon technical service representative evaluated the returned device and was able to confirm the reported image issue.The mac s4 passed visual inspection.When connected to verathon's test equipment, the mac s4 produced a normal image for about ten (10) seconds.Then the test monitor screen flashed and froze.A few seconds later, the display was filled with horizontal colored lines.The mac s4 failed verathon's device functionality testing.Review of complaint history for the reported lot number "td1015118" did not identify any previous complaints reported to verathon.Trending analysis for glidescope spectrum single-use 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.Upon completion of verathon's device evaluation, the mac s4 has been sent to verathon's engineering department for further investigation.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.
Additional Manufacturer Narrative
B4, g3, g6, h2, h6, h11.Following verathon's initial device evaluation, the subject glidescope spectrum single-use qc mac s4 was provided to verathon's engineering department for further investigation.Engineering analysis of the reported image freeze failure confirmed that the device initially operates as intended, followed by progressive image freezing, localized thermal increase of the camera sensor, and subsequent loss of image output.Failure analysis showed that the camera sensor stops functioning properly even though it is still receiving power and timing signals.It then begins to draw more current and generate heat.This behavior is consistent with an internal, temperature-related defect within the sensor.The root cause of the reported event was an internal failure of the camera sensor (u1), likely related to a temperature-dependent condition, which resulted in loss of image.

• 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 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: 23934781
• Report Number: 9615393-2025-00143
• Device Sequence Number: 18523585
• Product Code: CCW
• UDI-Device Identifier: 00879123007957
• UDI-Public: (01)00879123007957(10)TD1015118(11)250407(17)280407
• 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,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/28/2026

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: TD1015118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2025
• Supplement Date Received by Manufacturer: 02/19/2026; 04/20/2026
• Initial Report FDA Received Date: 12/31/2025
• Supplement Report FDA Received Date: 02/24/2026; 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2025
• 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