MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE VIDEO BATON 2.0 LARGE; LARYNGOSCOPE, RIGID

Model Number 0570-0382

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

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

Event Date 03/05/2024

Event Type  malfunction  

Event Description

A customer reported that during a patient procedure, using a glidescope video baton 2.0 large, the video was cutting in and out.It was reported that they were able to get it to work to complete the procedure by manipulating the connected glidescope core smart cable.No delay in the procedure or harm to the patient was reported.

Manufacturer Narrative

A replacement glidescope video baton 2.0 large was provided to the customer and the reported glidescope video baton 2.0 large was returned to verathon for evaluation along with the glidescope core smart cable used during the reported event.A verathon technical service representative evaluated the returned devices and was able to confirm the reported image issue.The video baton passed visual inspection.When connected to known, good, test verathon equipment, the video baton initially produced a normal image.However, when manipulating the connection between the test cable and the customer's video baton, it caused the image to flicker and split.The customer's video baton failed verathon's device functionality testing.Next, when connecting the customer's glidescope core smart cable to known, good, test verathon equipment, no image was produced and the test monitor failed to recognize the test imaging devices that were attached.The customer's smart cable failed verathon's device functionality testing.Upon completion of verathon's device evaluation, both the customer's video baton and smart cable were scrapped due to the customer already being provided replacements and there being no repairs available for the devices.Corrective action is not required at this time.Verathon will continue to monitor for trends.Reference the attached corresponding report containing the device information, event details and evaluation findings for the customer's returned glidescope core smart cable that was confirmed to have contributed to the reported event.

• Brand Name: GLIDESCOPE VIDEO BATON 2.0 LARGE
• 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: 18980435
• MDR Text Key: 339356433
• Report Number: 9615393-2024-00047
• Device Sequence Number: 1
• Product Code: CCW
• 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
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0570-0382
• Device Catalogue Number: 0570-0398
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/05/2023
• 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