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

Model Number	0570-0366
Medical Device Problem Codes	Erratic or Intermittent Display (1182); Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported that during intubation of a patient, using a glidescope go monitor, the screen goes out.Furthermore, it was reported that the monitor was not holding a charge and the connected glidescope spectrum single-use blade detaches easily.The procedure was completed using a different glidescope go monitor which was made available immediately.No delay in the procedure or harm to the patient was reported.
Additional Manufacturer Narrative
The reported glidescope go monitor was returned to verathon for evaluation.A verathon technical service representative (tsr) evaluated the returned monitor and was able to confirm the reported image issue.When connected to verathon's test equipment, the monitor produced intermittent video loss and split image.In addition, corrosion was observed on the monitor's hdmi connector pins.Furthermore, the tsr confirmed that the monitor failed to charge past fourteen (14) minutes.The customer's monitor failed verathon's device functionality testing and visual inspection.The monitor's hdmi connector was replaced with a test hdmi connector which the monitor then produced a normal image, therefore isolating the image issue to the hdmi connector being faulty.Resetting the monitor successfully resolved the power-management issue which the monitor then indicated two (2) hours and fifteen (15) minutes on full charge.The glidescope and gliderite products reprocessing manual states: "use hospital-grade clean air to blow remaining moisture out of the connectors, and then dry the component using either hospital-grade clean air or a clean, lint-free cloth." it is likely that not blowing out the connector with hospital-grade air or drying the connector with a clean, lint-free cloth may have caused or contributed to the corrosion in the hdmi connector.Verathon followed up with the customer and restated the importance of drying the connectors following the reprocessing of the monitor.Upon completion of the evaluation, the monitor 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
• Common Device Name: 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: 20262266
• Report Number: 9615393-2024-00121
• Device Sequence Number: 18233584
• Product Code: CCW
• UDI-Device Identifier: 00879123006189
• UDI-Public: (01)00879123006189(11)191025
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/22/2024

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
• Operator of Device: 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: 09/11/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2024
• Initial Report FDA Received Date: 09/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/29/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown