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); Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer's glidescope core system and bflex 2 regular 5.0 single-use bronchoscope were returned to verathon for evaluation.A verathon technical service representative (tsr) evaluated the returned devices but was unable to confirm the reported image issues.When connecting the customer's monitor to verathon's test equipment, the tsr could not duplicate any loss of video.The monitor was tested for thirty (30) minutes without any issues identified.No physical damage was identified via visual inspection.The monitor passed verathon's device functionality testing and confirmed to be within specification.Next, the customer's bflex bronchoscope was connected to verathon's test equipment for five (5) minutes with no identified video drop out.No physical damage was identified via visual inspection.The bflex bronchoscope passed verathon's device functionality testing and confirmed to be within specification.Lastly, the qc cable was connected to verathon's test equipment which also functioned as intended.However, visual inspection identified cracks and missing plastic around the cable's connector housing.While the tsr was unable to duplicate the reported failure, it is possible that the identified connector damage may have caused or contributed to the reported issue.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.Upon completion of verathon's device evaluation, the customer was notified about verathon's findings and advised to replace the damaged qc cable.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 system during a bronchoscopy procedure, the screen went black while visualizing the patient's lungs.The system was power-cycled but then displayed a blurry image with faint lines.The procedure could not be completed as there was no backup device available.The patient was already intubated at the time; however, no patient harm 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: 24944007
• Report Number: 9615393-2026-00054
• Device Sequence Number: 17453284
• Product Code: CCW
• UDI-Device Identifier: 00879123006578
• UDI-Public: (01)00879123006578(11)250114(10)18193-1-20
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/21/2026

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: 0600-0843
• Device Catalogue Number: 0800-0682
• Device Lot Number: 18193-1-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2025
• 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