MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE CORE 15-INCH MONITOR, REFURBISHED; LARYNGOSCOPE, RIGID

Model Number	R570-0404
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	12/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported refurbished glidescope core 15-inch monitor was returned to verathon for evaluation along with two (2) glidescope core 2m quickconnect cables used during the reported event.A verathon technical service representative evaluated the returned devices but was unable to confirm the reported image quality issue.When connecting the reported monitor to verathon's test equipment, no imaging issues were observed.The monitor passed verathon's device functionality testing and confirmed to be within specification.Next, the returned cables were evaluated and they passed both visual inspection and device functionality testing.The laryngoscope used with the glidescope system was not made available to verathon for evaluation.Upon completion of verathon's device evaluation, the monitor and both cables were returned to the customer.No further investigation is required at this time.Verathon will continue to monitor for trends.
Event or Problem Description
A customer reported that during an emergency care procedure, using a refurbished glidescope core 15-inch monitor, the picture was grainy with a white haze, making it difficult to visualize the patient's airway.The customer indicated that there was an unspecified delay due to the screen clarity; however, the procedure was successfully completed via direct laryngoscopy.No harm to the patient was reported.

• Brand Name: GLIDESCOPE CORE 15-INCH MONITOR, REFURBISHED
• Common Device Name: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): VERATHON MEDICAL ULC; 2227 douglas road; burnaby, british columbia V5C5A 9; CA V5C5A9
• Manufacturer (Section G): VERATHON MEDICAL ULC; 2227 douglas road; burnaby, british columbia V5C5A 9; CA V5C5A9
• Manufacturer Contact: corey kasbohm ; 20001 n creek pkwy; bothell, WA 98011-8218 ; 4256295760
• MDR Report Key: 24306232
• Report Number: 9615393-2026-00013
• Device Sequence Number: 5215145
• Product Code: CCW
• UDI-Device Identifier: 00879123009074
• UDI-Public: (01)00879123009074(11)191205
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 02/10/2026

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: R570-0404
• Device Catalogue Number: R270-1112
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2026
• Initial Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown