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

Model Number 0570-0313

Device Problems Poor Quality Image (1408); Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/04/2020

Event Type  malfunction  

Manufacturer Narrative

Upon review of the device history for the serial number (b)(4) it was determined that the device was manufactured on 30 oct 2017 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.The customer declined to have their video baton returned for evaluation and disposal.At this time, the cause of the reported issue could not be determined; however, it is likely that the age of the device, 2.6 years, caused or contributed to the event.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 avl video baton 3-4, the image was intermittent during intubation.The biomed reported that the cable felt kinked at the base of the baton.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 ; 6295760
• MDR Report Key: 10094307
• MDR Text Key: 193109377
• Report Number: 9615393-2020-00078
• 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 faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0570-0313
• 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: 04/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2017
• 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