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

Model Number	0570-0338
Medical Device Problem Code	Erratic or Intermittent Display (1182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that during a patient procedure, using a glidescope video monitor (gvm), the image was flickering.The customer reported that the flickering was slow and constant.No delay in the procedure, use of a backup device, or harm to the patient or user was reported.
Additional Manufacturer Narrative
The device return is anticipated, however; at the time of the report the device has not been received by verathon.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.
Additional Manufacturer Narrative
The reported glidescope video monitor was returned to verathon for evaluation.A verathon technical service representative evaluated the returned video monitor and was able to confirm the reported malfunction.When connecting the customer's glidescope video monitor to known, good, test verathon equipment, the image from the blade was flickering.Upon testing the monitor with a new back shell, the root cause was identified to be a failed main board.The main board was replaced and the device was tested and certified to be operating within specification.The camera image quality test was performed and passed.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: 14142396
• Report Number: 9615393-2022-00066
• Device Sequence Number: 16739818
• Product Code: CCW
• UDI-Device Identifier: 00879123003331
• UDI-Public: 010087912300333111180921
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2022

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
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2022
• Supplement Date Received by Manufacturer: 06/27/2022
• Initial Report FDA Received Date: 04/19/2022
• Supplement Report FDA Received Date: 06/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2018
• 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