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); Loose or Intermittent Connection (1371)

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

Event Date 01/25/2022

Event Type  malfunction  

Manufacturer Narrative

The customer declined the option to have their glidescope avl video baton 3-4 returned to verathon for evaluation.Upon review of the device history for the serial number (b)(4), it was determined that the device was manufactured on january 27, 2015 and is past the two (2) year expected product life as outlined in the glidescope operations and maintenance manual (omm).Since the device was not returned to verathon for evaluation, the cause could not be determined, but it is likely that the age of the device, seven (7) 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, the glidescope avl video baton 3-4 had a loose tip and intermittent picture.The procedure was completed using a different glidescope avl video baton 3-4 and glidescope avl monitor.No delay in the procedure 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: 13481420
• MDR Text Key: 287187607
• Report Number: 9615393-2022-00025
• 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: 01/28/2022

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/28/2022
• Initial Date FDA Received: 02/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2015
• 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