MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE SPECTRUM QC ECO MILLER S1; LARYNGOSCOPE, RIGID

Model Number	0574-0272
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	05/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer's glidescope spectrum single-use qc eco miller s1 was returned to verathon for evaluation.A verathon technical service representative (tsr) evaluated the returned device but was unable to confirm the reported image issue.When connected to verathon's test equipment, no blurry or "milky" image was observed.The tsr tried wiggling the connection and detaching and reattaching the laryngoscope, but no imaging issues were observed.The device passed verathon's device functionality testing and confirmed to be within specification.Neither the cable nor the monitor used with the laryngoscope during the reported event were made available to verathon for evaluation.Upon completion of verathon's device evaluation, the laryngoscope was scrapped due to being a single-use device.No further investigation is required at this time.Verathon will continue to monitor for trends.
Event or Problem Description
A customer reported while using a glidescope spectrum qc eco miller s1 laryngoscope, the image was very "milky" looking when intubating a patient in the pediatric intensive care unit (picu).The laryngoscope was removed from the patient and the camera was inspected to see if anything was blocking the image.The laryngoscope was reinserted and the milky image was still present.The laryngoscope was then replaced with another glidescope spectrum qc eco miller s1 and used to successfully intubate the patient.No procedural delay or patient harm was reported.

• Brand Name: GLIDESCOPE SPECTRUM QC ECO MILLER S1
• 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: 25600028
• Report Number: 9615393-2026-00081
• Device Sequence Number: 13242276
• Product Code: CCW
• UDI-Device Identifier: 00879123009241
• UDI-Public: (01)00879123009241
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/23/2026

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: 0574-0272
• Device Catalogue Number: 0270-1150
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2026
• Initial Report FDA Received Date: 06/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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