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

Model Number 0570-0420

Device Problems No Display/Image (1183); Display or Visual Feedback Problem (1184)

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

Event Date 02/08/2024

Event Type  malfunction  

Manufacturer Narrative

A replacement glidescope video baton quick connect large was provided to the customer and the reported glidescope video baton quick connect large used during the procedure was returned to verathon for evaluation.A verathon technical service representative evaluated the returned device and was able to confirm the reported image issue.When connecting the reported video baton to known, good, test verathon equipment, the image on the connected test monitor produced a poor quality image.The video baton's led was confirmed to illuminate when connected to the test equipment; however, upon visual inspection signs of fluid ingress under the lens were observed.The glidescope video baton quick connect large failed verathon's functionality testing.Upon completion of verathon's device evaluation, the glidescope video baton quick connect large was scrapped due to the customer already being provided a replacement and there being no repairs available for the device.Corrective action is not required at this time.Verathon will continue to monitor for trends.

Event Description

The customer reported that during a patient procedure, using a glidescope video baton quickconnect large, the light at the tip of the video baton failed to turn on when inserted down the patient's throat.As a result, the user was unable to visualize the patient's airway.The procedure was completed using an unknown backup device which was made available in an unspecified amount of time.No delay during the procedure or harm to the patient was reported.

• Brand Name: GLIDESCOPE VIDEO BATON QUICKCONNECT 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: 18789621
• MDR Text Key: 336970577
• Report Number: 9615393-2024-00038
• 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: 02/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0570-0420
• Device Catalogue Number: 0270-1058
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2022
• 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