MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE SPECTRUM SINGLE-USE LOPRO S3 LARYNGOSCOPE; LARYNGOSCOPE, RIGID

Model Number	0574-0194
Medical Device Problem Codes	Erratic or Intermittent Display (1182); Display or Visual Feedback Problem (1184)
Health Effect - Clinical Codes	Low Oxygen Saturation (2477); Diminished Pulse Pressure (2606)
Date of Event	12/09/2025
Type of Reportable Event	Serious Injury
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 that during an intubation attempt in the emergency department before surgery, using a glidescope spectrum single-use lopro s3 laryngoscope, the device's light source was dim and intermittently flickering on and off.Due to the reduced and inconsistent illumination, the clinician was unable to adequately visualize the airway, resulting in a prolonged intubation attempt.It was reported that the patient desaturated to 19% and experienced a loss of pulse.One round of cardiopulmonary resuscitation (cpr) was performed.A different glidescope system was obtained in an unspecified amount of time, and the airway was successfully secured on the second attempt.Patient demographic information and pre-existing medical conditions were declined to be provided by the facility upon request from verathon.
Additional Manufacturer Narrative
B4, g3, g6, h2, h6, h11 verathon's canadian distributor/importer reported on (b)(6), 2026 that the subject device return to verathon is anticipated and underway; however, at the time of this report, the device has not been received.Verathon notified the distributor on(b)(6), 2026 and (b)(6), 2026 informing them that the device was not yet received for evaluation.At this time, verathon does not expect the subject device to be returned to verathon for evaluation, therefore the cause of the reported issue could not be determined.Review of complaint history for the reported lot number "gt1013415" did not identify any previous complaints reported to verathon.Trending analysis for glidescope spectrum single-use lopro 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.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.

• Brand Name: GLIDESCOPE SPECTRUM SINGLE-USE LOPRO S3 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--821 ; 4256295760
• MDR Report Key: 23880246
• Report Number: 9615393-2025-00140
• Device Sequence Number: 4771313
• Product Code: CCW
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (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,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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 0574-0194
• Device Catalogue Number: 0270-0938
• Device Lot Number: GT1013415
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2025
• Supplement Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/30/2025
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown