MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE SPECTRUM LOPRO S3; LARYNGOSCOPE, RIGID

Model Number 0574-0194

Device Problem Erratic or Intermittent Display (1182)

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

Event Date 12/02/2020

Event Type  malfunction  

Manufacturer Narrative

The customer declined the option to have their glidescope spectrum lopro s3 returned to verathon for evaluation.Since the device was not returned to verathon, the cause of the failure could not be determined.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 spectrum lopro s3, the monitor flickered and there were lines moving across the screen.By exchanging blades, the customer isolated the problem to the blade.No delay in the procedure, use of a backup device, or harm to the patient or user was reported.

Manufacturer Narrative

The glidescope spectrum lopro s3 was returned to verathon for evaluation.A verathon representative evaluated the returned spectrum lopro s3 and could not reproduce the flickering image issue; the unit functioned as intended.The glidescope spectrum lopro s3 was retained.No further investigation is required at this time.Verathon will continue to monitor for trends.

• Brand Name: GLIDESCOPE SPECTRUM LOPRO S3
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): VERATHON MEDICAL ULC; 2227 douglas road; burnaby, british columbia V5C 5 A9; CA V5C 5A9
• MDR Report Key: 11060822
• MDR Text Key: 224637969
• Report Number: 9615393-2020-00277
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 12/02/2020

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: 0574-0194
• Device Catalogue Number: 0270-0938
• Device Lot Number: GT67492
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2021
• Initial Date Manufacturer Received: 12/02/2020
• Initial Date FDA Received: 12/22/2020
• Supplement Dates Manufacturer Received: 02/24/2021
• Supplement Dates FDA Received: 03/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1