MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE AVL VIDEO BATON 3-4; LARYNGOSCOPE, RIGID

Model Number 0570-0307

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 02/27/2024

Event Type  malfunction  

Event Description

A customer reported that during a patient procedure, using a glidescope avl video baton 3-4, the image on the connected monitor intermittently glitches and either turns black or has green lines on the screen.The customer reported isolating the issue to the glidescope avl video baton 3-4 after duplicating the issue during their evaluation.No delay in the procedure, use of a backup device, or harm to the patient was reported.

Manufacturer Narrative

The customer declined the option to have their glidescope avl video baton 3-4 returned to verathon for evaluation.Since the device was not returned to verathon for evaluation, the cause could not be determined.Upon review of the device history for the serial number (b)(6) it was determined that the device was manufactured on december 10, 2019 and is past the two (2) year expected product life as outlined in the glidescope operations and maintenance manual (omm).Due to the age of the device and the fact that there are no repairs available for the video baton, the customer was advised to replace their glidescope avl video baton 3-4.At this time, the cause of the reported issue could not be determined; however, it is likely that the age of the device, four (4) years and three (3) months, may have caused or contributed to the event.Review of complaint history for the reported serial number did not identify any previous complaints reported to verathon.Trending analysis for the glidescope avl video baton 3-4 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.Corrective action is currently not required at this time.Verathon will continue to monitor for any ongoing trends.

• Brand Name: GLIDESCOPE AVL VIDEO BATON 3-4
• 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: 18840726
• MDR Text Key: 337644670
• Report Number: 9615393-2024-00045
• 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: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0570-0307
• Device Catalogue Number: 0570-0313
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/10/2019
• 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