MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE CORE SMART CABLE; LARYNGOSCOPE, RIGID

Model Number	0600-0783
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	07/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported during an emergency care procedure, while using a glidescope core smart cable, the screen on the connected glidescope core 15-inch fhd monitor was dim and the picture was fuzzy.The customer reported changing out the blade which initially made the system work better, but then the image issue recurred.After re-connecting a blade to the cable, they were able to see at that point.They reported no cables were switched out but a small crack was noticed in the cable itself.The customer reported there were multiple other issues that caused a delay during the procedure including the patient's pre-existing condition.No harm to the patient was reported.
Additional Manufacturer Narrative
A replacement glidescope core smart cable was provided to the customer.The reported smart cable was returned to verathon for evaluation along with the glidescope core 15-inch fhd monitor used during the reported event.A verathon technical service representative (tsr) evaluated the returned devices but was unable to confirm the reported image issue.When connecting the customer's smart cable and monitor to a verathon test blade, they were found to be working as intended.The tsr tried wiggling the connections, detaching and reattaching the test blade and cable, power-cycled the monitor with the test blade and cable attached, and swapped between the a and b ports of the monitor.No irregular dimness, blurry, or fuzzy image was observed.Visual inspection found no physical damaged to the smart cable.Both the smart cable and monitor passed verathon's device functionality testing and confirmed to be within specification.The laryngoscope(s) used during the reported event were not made available to verathon for evaluation.Upon completion of verathon's device evaluation, the customer's smart cable was scrapped due to already being provided a replacement.The monitor was also returned to the customer.No further investigation is required at this time.Verathon will continue to monitor for trends.

• Brand Name: GLIDESCOPE CORE SMART CABLE
• 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: 22654130
• Report Number: 9615393-2025-00084
• Device Sequence Number: 8816296
• Product Code: CCW
• UDI-Device Identifier: 00879123006752
• UDI-Public: (01)00879123006752(11)240819
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/29/2025

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: 0600-0783
• Device Catalogue Number: 0800-0602
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2025
• Initial Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2024
• 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