MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE CORE 2M QUICKCONNECT CABLE; LARYNGOSCOPE, RIGID

Model Number	0600-0843
Medical Device Problem Codes	Erratic or Intermittent Display (1182); Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer's glidescope core 15-inch fhd monitor was returned to verathon for evaluation along with the glidescope core 2m quickconnect cable used during the procedure.A verathon technical service representative (tsr) evaluated the customer's devices but was unable to confirm the reported image issue.The tsr power-cycled the monitor twenty (20) times, swapped test video batons ten (10) times, and recorded fifteen (15) minutes of video while rapidly changing modes fifteen (15) times.The reported image issue could not be replicated.The monitor and cable passed verathon's device functionality testing and confirmed to be within specification.Upon completion of verathon's device evaluation, the system was sent to verathon's engineering department for further investigation.A supplemental report will be submitted by verathon in accordance with 21 cfr 803.56 once additional information becomes available.Corrective action is not required at this time.Verathon will continue to monitor for trends.
Event or Problem Description
A customer reported while using a glidescope core 15-inch fhd monitor, the display went dark during a bronchoscopy and kept freezing.No delay in the procedure, use of a backup device, or harm to the patient was reported.
Additional Manufacturer Narrative
B4, d1, d4, g3, g6, h2, h6, h11.Following verathon's initial device evaluation, further engineering investigation of the customer's entire glidescope core system was able to reproduce the reported image issue.A verathon engineering representative was able to reproduce the dark screen issue by moving and jiggling the customer's glidescope core 2m quickconnect cable while it was connected to a bflex bronchoscope.Visual inspection identified damage around the cable connector's magnetic post, cracks in the plastic housing, and the magnet rattling around inside the connector.The identified damage may cause the connection of the cable to the bflex bronchoscope to be weakened and lead to an intermittent connection.The glidescope core operations and maintenance manual (omm) notes, "before every use, ensure that the instrument is operating correctly and has no sign of damage.Do not use this product if the device appears damaged." verathon followed up with the customer and restated the importance of checking the device before its use in a procedure.Following verathon's engineering investigation, the customer's glidescope core 2m quickconnect cable was replaced and the glidescope core system was returned to the customer.Corrective action is not required at this time.Verathon will continue to monitor for trends.

• Brand Name: GLIDESCOPE CORE 2M QUICKCONNECT 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: 22321027
• Report Number: 9615393-2025-00071
• Device Sequence Number: 21063809
• Product Code: CCW
• UDI-Device Identifier: 00879123006578
• UDI-Public: 00879123006578
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2025

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: 0600-0843
• Device Catalogue Number: 0800-0682
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2025
• Supplement Date Received by Manufacturer: 07/09/2025
• Initial Report FDA Received Date: 06/24/2025
• Supplement Report FDA Received Date: 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2024
• 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