MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE VIDEO MONITOR (GVM); LARYNGOSCOPE, RIGID

Model Number	0570-0338
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	08/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received by verathon, however; at the time of the report the device has not been evaluated.Verathon continues to investigate the reported event and a supplemental report will be submitted in accordance with 21 cfr 803.56 when additional information becomes available.
Event or Problem Description
The customer reported that during a patient procedure, using a glidescope video monitor (gvm), the screen was flickering.No delay in the procedure, use of a backup device, or harm to the patient was reported.
Additional Manufacturer Narrative
The reported glidescope video monitor was returned to verathon for evaluation.A verathon technical service representative (tsr) evaluated the returned video monitor and was able to confirm the reported image failure.When connecting the customer's glidescope video monitor to known, good, test verathon equipment, the image was intermittent.Upon visual inspection, the tsr observed corrosion on the monitor's connector pins.The customer's video monitor failed verathon's device functionality testing.The tsr replaced the monitor's back shell and was no longer able to recreate the intermittent image issue.Upon completion of the evaluation and repair, the glidescope video monitor was returned to the customer.Corrective action is not required at this time.Verathon will continue to monitor for any ongoing trends.

• Brand Name: GLIDESCOPE VIDEO MONITOR (GVM)
• 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: 17730372
• Report Number: 9615393-2023-00166
• Device Sequence Number: 20367129
• Product Code: CCW
• UDI-Device Identifier: 00879123003331
• UDI-Public: 010087912300333111180724
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2023

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: 0570-0338
• Device Catalogue Number: 0570-0338
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2023
• Supplement Date Received by Manufacturer: 09/07/2023
• Initial Report FDA Received Date: 09/12/2023
• Supplement Report FDA Received Date: 09/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2018
• 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