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

Model Number 0600-0767

Device Problems Erratic or Intermittent Display (1182); Display or Visual Feedback Problem (1184); Poor Quality Image (1408)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/22/2023

Event Type  malfunction  

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 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.

• Brand Name: GLIDESCOPE CORE QUICKCONNECT CABLE
• Type of Device: 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
• MDR Text Key: 331203396
• Report Number: 9615393-2023-00228
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 11/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1