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	08/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer's glidescope video monitor (gvm) was returned to verathon for evaluation.A verathon technical service representative evaluated the returned monitor but was unable to confirm the reported image failure.When connected to known, good, test verathon equipment and left powered on for fifteen (15) minutes, no sign of image failure was observed.The customer's monitor passed verathon's device functionality testing.The cable used with the monitor during the reported event was not made available to verathon for evaluation.Upon completion of verathon's device evaluation, the monitor was returned to the customer.Verathon also followed up with the customer regarding the device evaluation findings and offered to arrange for the cable to be returned for evaluation.To date, no response has been received from the customer.No further investigation is required at this time.Verathon will continue to monitor for trends.
Event or Problem Description
A customer reported that during a patient procedure, using a glidescope video monitor (gvm), the picture was going in and out intermittently.The procedure was completed using a backup device which was made available in an unspecified amount of time.The customer reported being unable to isolate the issue to the monitor or cable.No delay in the procedure or harm to the patient was reported.

• 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: 17683789
• Report Number: 9615393-2023-00175
• Device Sequence Number: 16783872
• Product Code: CCW
• UDI-Device Identifier: 00879123003331
• UDI-Public: 010087912300333111180710
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 08/08/2023

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: 08/16/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2023
• Initial Report FDA Received Date: 09/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2018
• 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