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); No Display/Image (1183)

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

Event Date 10/13/2022

Event Type  malfunction  

Event Description

The customer reported that during a patient procedure, using a glidescope avl video baton 3-4, the image intermittently "flickers" and then disappears.The customer was able to complete the procedure by manipulating the video baton until the image reappeared.No reports of a delay in the procedure, use of a backup device, or harm to the patient or user was reported.

Manufacturer Narrative

A replacement glidescope avl video baton 3-4 was provided to the customer, and the reported video baton was returned to verathon for evaluation.A verathon technical service representative evaluated the video baton and confirmed the reported image issue.When connecting the reported video baton to a known, good, test glidescope video monitor, the image on the test monitor produced an intermittent image.When the verathon technical service representative manipulated the video baton's cable, the image would disappear entirely.Upon visual inspection of the device, the verathon technical service representative reported seeing damage to both the video baton's housing and lens.The camera image quality test was performed and failed for the reported glidescope avl video baton 3-4.Upon completion of the evaluation the reported glidescope avl video baton 3-4 was scrapped as it had already been replaced prior to its return to verathon, and there being no repairs available for this device.Corrective action is currently not required at this time.Verathon will continue to monitor for 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: 15753235
• MDR Text Key: 307713111
• Report Number: 9615393-2022-00184
• 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: 10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2022
• 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: 10/31/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/30/2014
• 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