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

Model Number 0570-0307

Device Problem No Visual Prompts/Feedback (4021)

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

Event Date 10/24/2022

Event Type  malfunction  

Manufacturer Narrative

The reported glidescope video baton 3-4 was returned to verathon for evaluation, along with the glidescope video monitor (gvm) used in the reported procedure.A verathon technical service representative evaluated the returned devices and confirmed the reported image issue.When connecting the reported video baton to the returned video monitor, the image produced green static, and the video baton ceases to be recognized whenever the video baton's flex tube was manipulated.Upon visual inspection of the video baton, the verathon technical service representative also identified damage to the video baton's lens cover.The camera image quality test was performed and failed for the reported glidescope video baton 3-4.The verathon technical service representative next evaluated the returned glidescope video monitor by connecting the device to a known, good, test glidescope video baton 3-4.They confirmed the glidescope video monitor's image on its display was normal; no issues were found.The camera image quality test was performed and passed for the returned glidescope video monitor.The reported image issue was isolated to just the glidescope video baton 3-4.Upon completion of the evaluation the customer's video monitor was provided additional servicing per customer approval, and they were also notified of the image issues found to their glidescope video baton 3-4, with the recommendation to replace the video baton due to there being no repairs available for this device.The customer's glidescope video monitor was serviced and returned, along with their glidescope video baton 3-4, which was returned "as-is" per their request.At this time corrective action is not required.Verathon will continue to monitor for trends.

Event Description

The customer reported that during a patient procedure, using a glidescope avl video baton 3-4, the image had static and intermittently froze.No delay in the procedure, use of a backup device, or harm to the patient or user 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: 15845649
• MDR Text Key: 307623018
• Report Number: 9615393-2022-00191
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/25/2022

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: 0570-0307
• Device Catalogue Number: 0570-0313
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/25/2022
• Initial Date FDA Received: 11/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2016
• 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