MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE SPECTRUM QC ECO HYPERANGLE S4, NON-STERILE; LARYNGOSCOPE, RIGID

Model Number	0574-0268
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer's glidescope spectrum qc eco hyperangle s4 blade was returned to verathon for evaluation.A verathon technical service representative evaluated the device and confirmed the reported issue of no light illumination.When connected to verathon's test equipment, the blade's camera produced an image as intended; however, the light-emitting-diode (led) failed to illuminate.The blade failed verathon's device functionality testing.Review of complaint history for the reported device did not identify any previous complaints reported to verathon for the same failure mode.Trending analysis for glidescope spectrum qc eco 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 blade was 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.
Event or Problem Description
A customer reported the light failed to illuminate when using a glidescope spectrum qc eco hyperangle s4, non-sterile blade during an intubation procedure.It was further reported that the light failure was identified when the blade was introduced into the patient's mouth.The blade was exchanged and the procedure continued uneventfully using a replacement blade.No delay in procedure or harm to the patient was reported.

• Brand Name: GLIDESCOPE SPECTRUM QC ECO HYPERANGLE S4, NON-STERILE
• 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: 25280630
• Report Number: 9615393-2026-00062
• Device Sequence Number: 21273653
• Product Code: CCW
• UDI-Device Identifier: 00879123009203
• UDI-Public: (01)00879123009203(10)QQ1024037(11)260303(17)290303
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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): 07/21/2026

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: 0574-0268
• Device Catalogue Number: 0270-1146
• Device Lot Number: QQ1024037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2026
• Supplement Date Received by Manufacturer: 07/20/2026
• Initial Report FDA Received Date: 05/26/2026
• Supplement Report FDA Received Date: 07/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2026
• 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