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); Poor Quality Image (1408)

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

Event Date 11/27/2023

Event Type  malfunction  

Event Description

A customer reported that during a patient procedure, using a glidescope video baton 2.0 large, the image was pixelated, grainy, and cut out completely when the video baton was inserted into the patient.The procedure was completed using a different glidescope system which was made available in an unspecified time.No delay in the procedure or harm to the patient was reported.

Manufacturer Narrative

The device has been received by verathon, however; at the time of the report the device has not been evaluated.Verathon continues to investigate the reported event and a supplemental report will be submitted in accordance with 21 cfr 803.56 when additional information becomes available.

Manufacturer Narrative

The reported glidescope video baton 2.0 large was returned to verathon for evaluation along with the glidescope core 10-inch monitor and 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 issues.When connecting the glidescope video baton 2.0 large to known, good, test verathon equipment, the screen was blank and the video baton led blinks.Visual inspection of the video baton identified the lens was scratched.Upon visual inspection of the glidescope core smart cable, no visible damaged was identified; however, intermittent connection with the video baton was confirmed.The image issues were isolated to both the glidescope video baton 2.0 large and the glidescope core smart cable.Upon completion of verathon's device evaluation, both the video baton and smart cable were replaced.Corrective action is not required at this time.Verathon will continue to monitor for ongoing trends.Reference the attached corresponding report containing the device information and evaluation findings for the customer's returned glidescope core smart cable that was confirmed to be a contributing factor 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: 18426257
• MDR Text Key: 331890214
• Report Number: 9615393-2024-00001
• Device Sequence Number: 1
• Product Code: CCW
• UDI-Device Identifier: 10879123006568
• UDI-Public: (01)10879123006568(11)220414
• 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,Followup
• Report Date: 12/05/2023

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
• 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: 12/26/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2023
• Initial Date FDA Received: 01/02/2024
• Supplement Dates Manufacturer Received: 01/03/2024
• Supplement Dates FDA Received: 01/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2022
• 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