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

Model Number 0570-0313

Device Problem Image Display Error/Artifact (1304)

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

Event Date 02/18/2020

Event Type  malfunction  

Manufacturer Narrative

The device return is anticipated; however, at the time of the report the device has not been received by verathon.Verathon continues to investigate the reported event and a supplemental report will be submitted in accordance with 21 cfr 803.56 when additional information becomes available.Upon review of the device history for the serial number (b)(4).It was determined that the device was manufactured on april 12, 2012 and is past the two (2) year expected product life as outlined in the glidescope operations and maintenance manual (omm).

Event Description

The customer reported that during a patient procedure, using a glidescope avl video baton 3-4, the image had static and would go in and out when the cable was moved.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: 9845721
• MDR Text Key: 189992795
• Report Number: 9615393-2020-00037
• 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: 02/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0570-0313
• Device Catalogue Number: 0570-0313
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2012
• 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