MAUDE Adverse Event Report: VERATHON MEDICAL ULC GGLIDESCOPE SPECTRUM SINGLE-USE QC HYPERANGLE S3; LARYNGOSCOPE, RIGID

Model Number	0574-0225
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	04/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was returned to verathon for evaluation.A verathon technical service representative evaluated the device and confirmed the reported blurry image.Visual inspection did not identify any visible damage or debris on the device; however it failed verathon's device functionality testing.Upon completion of verathon's device evaluation, the device will be provided 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.
Event or Problem Description
A customer reported that during an emergency cesarean section procedure, the glidescope spectrum single-use qc hyperangle s3 blade provided a very cloudy image, resulting in poor visualization.The blade was replaced with another blade, which performed as expected.No delay in procedure or harm to the patient was reported.

• Brand Name: GGLIDESCOPE SPECTRUM SINGLE-USE QC HYPERANGLE S3
• 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: 25231608
• Report Number: 9615393-2026-00059
• Device Sequence Number: 5081637
• Product Code: CCW
• UDI-Device Identifier: 00879123007926
• UDI-Public: (01)00879123007926(10)TA1024080(11)251212(17)281212
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2026

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: 0574-0225
• Device Catalogue Number: 0270-1083
• Device Lot Number: TA1024080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2026
• Supplement Date Received by Manufacturer: 06/03/2026
• Initial Report FDA Received Date: 05/20/2026
• Supplement Report FDA Received Date: 06/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2025
• 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