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

Model Number	0600-0843
Medical Device Problem Codes	Break (1069); 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	04/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported during a bedside bronchoscopy, using a glidescope core 2m quickconnect cable, the display on the connected glidescope core 15-inch fhd monitor went black and then had green and pink lines across the screen.The light stayed on at the end of the bflex2 single-use bronchoscope.The users unplugged the bronchoscope and it resumed normal function.It was also reported that the cable was broken at the connection point.No delay in procedure, use of a backup device, or harm to the patient was reported.
Additional Manufacturer Narrative
The reported glidescope core 2m quickconnect (qc) cable used during the procedure was returned to verathon for evaluation along with the customer's glidescope core 15-inch fhd monitor, glidescope core smart cable, and bflex2 single-use bronchoscope.A verathon technical service representative (tsr) evaluated the returned devices and was able to confirm the reported image issue.Upon visual inspection, the tsr identified the qc cable connector was broken and a piece wedged in the connector preventing connection with the bronchoscope.The customer's qc cable failed verathon's device functionality testing.The tsr evaluated all other returned devices and did not identify any further issues, therefore isolating the issue to only the qc cable.Upon completion of verathon's device evaluation, a replacement qc cable was provided to the customer along with returning their monitor and smart cable.The bronchoscope was scrapped due to being a single-use device.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.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: 21969214
• Report Number: 9615393-2025-00049
• Device Sequence Number: 18230417
• Product Code: CCW
• UDI-Device Identifier: 00879123006578
• UDI-Public: (01)00879123006578(10)17920-1-11(11)240826
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/06/2025

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: 17920-1-11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2025
• Initial Report FDA Received Date: 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2024
• 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