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

Model Number 0570-0307

Device Problems Display or Visual Feedback Problem (1184); Poor Quality Image (1408); Deformation Due to Compressive Stress (2889)

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

Event Date 09/25/2023

Event Type  malfunction  

Manufacturer Narrative

The customer was provided a replacement glidescope avl video baton 3-4 and the reported glidescope avl video baton 3-4 was returned to verathon for evaluation.A verathon technical service representative (tsr) evaluated the returned video baton.Upon visual inspection, the tsr was unable to confirm the video baton being snapped in half; however, the lens cover was noted as missing plastic.When connected to known, good, test verathon equipment, the video baton displayed intermittent, horizontal green lines.The video baton failed verathon's device functionality testing.The glidescope video laryngoscopes operations and maintenance manual (omm) notes that "before every use, ensure that the instrument is operating correctly and has no sign of damage.Do not use this product if the device appears damaged." verathon followed up with the customer and restated the importance of checking the device before its use in a procedure.Upon review of the device history for the glidescope avl video baton serial number "(b)(6)," it was determined that the device was manufactured on april 6, 2015 and is past the two (2) year expected product life as outlined in the glidescope video laryngoscopes omm.Due to the age of the device and the fact that there are no repairs available for the device, the customer's glidescope avl video baton 3-4 was replaced.Corrective action is not required at this time.Verathon will continue to monitor for trends.

Event Description

A customer reported that during a patient procedure, using a glidescope avl video baton 3-4, the video baton was "snapped in half" causing the image to become distorted and the user was unable to visualize anything.Follow-up information received from the customer reported that the video baton was "bent and the fibers inside have been broken from being pushed repeatedly into the [baton] holder." the procedure was completed using a backup video baton 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 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: 17996009
• MDR Text Key: 326385209
• Report Number: 9615393-2023-00202
• 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: 09/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2023
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2015
• 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