MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE CORE 15-INCH FHD MONITOR; LARYNGOSCOPE, RIGID

Model Number 0570-0437

Device Problems Display or Visual Feedback Problem (1184); Poor Quality Image (1408)

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

Event Date 03/28/2024

Event Type  malfunction  

Event Description

During a patient procedure, the customer reported experiencing green and pink lines across the screen of their glidescope core 15-inch fhd monitor.The customer experienced the same issue while using a glidescope spectrum single-use quickconnect blade and cable as well as a glidescope spectrum single-use lopro blade and cable.There were no reports of delay in procedure, use of a back-up device, or harm to the patient.

Manufacturer Narrative

A verathon sales representative went to the customer facility and tested the device but was unable to replicate the reported issue.The customer also stated they have used the monitor a few times since the incident; however, they have not been able to replicate the issue either.The reported glidescope core 15-inch fhd monitor was returned to verathon for evaluation.A verathon technical service representative (tsr) evaluated the returned device and was not able to confirm the customer's report of an image issue with the monitor.When connected to verathon's known, good test equipment, the monitor produced a normal image.The verathon tsr power cycled the glidescope core 15-inch fhd monitor ten times with various test equipment attached and ten times with no test equipment attached.No failures were observed during the testing.The monitor passed verathon's device functionality testing as well as visual inspection.There were no signs of damage or debris observed with the onanon connectors.All internal connectors were noted to be secure.The customer's laryngoscopes and cables, that were connected to the monitor during the reported incident, were not made available to verathon for evaluation.Upon completion of verathon's device evaluation, the glidescope core 15-inch fhd monitor was returned to the customer.No further investigation is required at this time.Verathon will continue to monitor for trends.

• Brand Name: GLIDESCOPE CORE 15-INCH FHD 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: 19116943
• MDR Text Key: 341034309
• Report Number: 9615393-2024-00062
• Device Sequence Number: 1
• Product Code: CCW
• UDI-Device Identifier: 00879123008596
• UDI-Public: 010087912300859611231212
• 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,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/01/2024

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: 0570-0437
• 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: 04/01/2024
• Initial Date FDA Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2023
• 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