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

Model Number 0570-0366

Device Problems Erratic or Intermittent Display (1182); Display or Visual Feedback Problem (1184)

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

Event Date 04/05/2024

Event Type  malfunction  

Event Description

During a patient procedure, the customer reported experiencing the screen intermittently turning on and off (loss of image) while using the glidescope go monitor.There were no reports of delay in procedure, use of a backup device, or harm to the patient.

Manufacturer Narrative

The reported glidescope go monitor, that was used during the procedure, was returned to verathon for evaluation.A verathon technical service representative (tsr) evaluated the returned device and was able to confirm the reported image issue.When connected to verathon's known, good, test equipment, the monitor intermittently would experience loss of image while adjusting the imaging device/movable arm.However, when a verathon test hdmi connector was attached to the monitor, the tsr was unable to recreate the issue.The issue was isolated to the monitors hdmi connector.Upon completion of verathon's device evaluation, the hdmi connector was replaced on the monitor and 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 rd; burnaby, british columbia V5C 5 A9; CA V5C 5A9
• Manufacturer (Section G): VERATHON MEDICAL ULC; 2227 douglas rd; 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: 19164540
• MDR Text Key: 341361536
• Report Number: 9615393-2024-00064
• Device Sequence Number: 1
• Product Code: CCW
• UDI-Device Identifier: 00879123006189
• UDI-Public: 010087912300618911210222
• 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: 04/08/2024

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: 04/10/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/08/2024
• Initial Date FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2021
• 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