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

Model Number 0600-0783

Device Problems Erratic or Intermittent Display (1182); Display or Visual Feedback Problem (1184)

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

Event Date 02/21/2024

Event Type  malfunction  

Manufacturer Narrative

The customer's glidescope core smart cable was returned to verathon for evaluation along with the glidescope core 15-inch fhd monitor used during the reported procedure.A verathon technical service representative (tsr) evaluated the returned devices but was unable to confirm the reported image issue.When connected to known, good, test verathon equipment, the system produced a normal image.Rapidly swapping the test imaging device and monitor produced a normal image throughout testing.The tsr did not observe the image cutting out after the imaging device was attached.The monitor was power-cycled 15 times and no issues were observed.Both the cusotmer's smart cable and monitor passed verathon's device functionality testing.The customer's laryngoscope that was connected to the smart cable and monitor during the reported incident was not made available to verathon for evaluation.Upon completion of verathon's device evaluation, both the smart cable and monitor were returned to the customer.No further investigation is required at this time.Verathon will continue to monitor for trends.

Event Description

A customer reported that during a patient procedure, using a glidescope core smart cable, the screen on the connected glidescope core 15-inch fhd monitor blacked out for five (5) seconds and then turned back on.They reported initially being able to visualize the vocal cords while intubating the patient and were about to pass the tube when it went blank.It was reported that the device did not power off as it was fully charged and plugged in but that it went black for five seconds before the image reappeared and they were able to complete the intubation.Following the reported incident, neither the customer nor their verathon territory manager were able to replicate the issue; however, the laryngoscope used during the procedure was not saved.No delay in the procedure, use of a backup device, or harm to the patient was reported.

• Brand Name: GLIDESCOPE CORE SMART 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: 18933441
• MDR Text Key: 338450840
• Report Number: 9615393-2024-00043
• Device Sequence Number: 1
• Product Code: CCW
• UDI-Device Identifier: 00879123006509
• UDI-Public: 010087912300650911240103
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 02/23/2024

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
• Device Operator: Health Professional
• Device Model Number: 0600-0783
• Device Catalogue Number: 0800-0602
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/23/2024
• Initial Date FDA Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/03/2024
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1