MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE GO MONITOR; LARYNGOSCOPE, RIGID

Model Number 0570-0366

Device Problems Erratic or Intermittent Display (1182); No Display/Image (1183); Display or Visual Feedback Problem (1184)

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

Event Date 10/06/2022

Event Type  malfunction  

Event Description

The customer reported that during a patient procedure, using a glidescope go monitor, the image produced several lines across the monitor screen and the image would also intermittently disappear.The customer reported trying several glidescope spectrum single-use video laryngoscopes with the glidescope go monitor but the same reported image issue occurred.The procedure was completed using a backup glidescope core system, which was made readily available for use.No harm to the patient was reported.

Manufacturer Narrative

The reported glidescope go monitor was returned to verathon for evaluation.A verathon technical service representative evaluated the reported video monitor and was able to confirm the reported image issues.When connecting the reported video monitor to known, good, test verathon equipment, the video monitor produced lines, split screen, or a green image.Articulating the device did not have any effect.The camera image quality test was performed for the video monitor and failed.The issue was isolated to the monitor's failed hdmi connector.Upon completion of the evaluation, the video monitor's hdmi connector was replaced and the device was returned to the customer.Corrective action is not required at this time.Verathon will continue to monitor for trends.

• Brand Name: GLIDESCOPE GO MONITOR
• 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: 16051958
• MDR Text Key: 308357129
• Report Number: 9615393-2022-00232
• 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: Nurse
• Type of Report: Initial
• Report Date: 12/06/2022

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: 0570-0366
• Device Catalogue Number: 0570-0368
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2022
• Initial Date FDA Received: 12/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2022
• 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