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	09/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported glidescope core 2m quickconnect cable was returned to verathon for evaulation along with the bflex 2 5.8 single-use bronchoscope used during the reported procedure.A verathon technical service representative evaluated the returned cable but was unable to confirm the reported image issue.When connected to a test monitor and bflex bronchoscope, the cable worked as intended.The device passed verathon's device functionality testing and was confirmed to be within specification.The returned bflex bronchoscope was unable to be tested due to being contaminated with blood and labeled with a warning of staph infection from the patient the device was used on.Upon completion of verathon's device evaluation, the cable was returned to the verathon territory manager and the bronchoscope was scrapped.No further investigation is required at this time.Verathon will continue to monitor for trends.
Event or Problem Description
A verathon territory manager reported on behalf of their customer that when a bflex 2 large 5.8 single-use bronchoscope was plugged in to a glidescope core 2m quickconnect cable during a tracheostomy procedure, the screen on the connected glidescope core 15-inch fhd monitor was cutting out and had a definite lag.Mid-procedure, the bronchoscope was swapped to a different glidescope core quickconnect cable and there were no issues with the screen cutting out and lag.No delay in procedure or harm to the patient was reported.

• 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: 23292388
• Report Number: 9615393-2025-00115
• Device Sequence Number: 13268903
• Product Code: CCW
• UDI-Device Identifier: 00879123006578
• UDI-Public: 00879123006578
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/14/2025

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: 09/23/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2025
• Initial Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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