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

Model Number	0600-0767
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	11/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer declined the option to have the reported glidescope core quickconnect cable returned to verathon for evaluation.Since the device was not returned to verathon for evaluation, the cause could not be determined.Review of complaint history found that this customer reported one similar incident using a different glidescope core quickconnect cable.Follow-up information received from the customer's verathon territory manager reported that this most recent incident ocurred after replacing their initial glidescope core quickconnect cable and using a different generation of bflex single-use bronchoscope with a loaner glidescope core 15-inch monitor.The customer was unable to isolate the issue to a particular system component.The customer's verathon territory manager reported that the customer will be replacing their glidescope core system following the reported event.Trending analysis for the glidescope core quickconnect cables does not identify any trends exceeding acceptable limits.Review of the system risk assessment confirmed that the risk associated with the hazardous scenario has been adequately captured and characterized by verathon.Corrective action is currently not required at this time.Verathon will continue to monitor for any ongoing trends.
Event or Problem Description
A customer reported that during a patient procedure, using a glidescope core quickconnect cable, black and grey scrambled lines appeared on the connected glidescope core 15-inch monitor with a bflex 2 large 5.8 single-use bronchoscope.The procedure was completed using a backup glidescope system but the same bflex 2 large 5.8 single-use bronchoscope which was made available in an unspecified amount of time.No delay in the procedure or harm to the patient was reported.
Additional Manufacturer Narrative
**udi related data quality updates only**.This is a supplemental report correcting the unique device identifier (udi) information in section d4.In the initial report submission, the udi information field was left blank due to the subject device lot number and manufacture date being unknown.Despite verathon being unable to obtain the lot information from the customer, this supplemental report provides the udi-di for the subject device model.

• Brand Name: GLIDESCOPE CORE 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: 18356957
• Report Number: 9615393-2023-00228
• Device Sequence Number: 6426963
• Product Code: CCW
• UDI-Device Identifier: 00879123006356
• UDI-Public: (01)00879123006356
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2023

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: 0600-0767
• Device Catalogue Number: 0800-0605
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/19/2023
• Supplement Report FDA Received Date: 09/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown