MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE VIDEO BATON 2.0 LARGE; LARYNGOSCOPE, RIGID

Model Number	0570-0382
Medical Device Problem Code	Erratic or Intermittent Display (1182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer's glidescope video baton 2.0 large was returned to verathon for evaluation along with the glidescope core 10-inch monitor and glidescope core smart cable used during the reported event.A verathon technical service representative evaluated the returned system components and was able to confirm the reported image issue.Upon visual inspection, no visible damage was identified to the monitor or smart cable.When inspecting the video baton, the camera tip to flex tube connection was found to be loose.When connecting the video baton to known, good, test verathon equipment, the image froze.The video baton failed verathon's device functionality testing and the issue was isolated to just the video baton.Upon completion of verathon's device evaluation, the glidescope video baton 2.0 large was replaced and the monitor and smart cable were returned to the customer.Corrective action is not 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 baton 2.0 large, the image was cutting out intermittently.No delay in the procedure, use of a backup device, or harm to the patient was reported.
Additional Manufacturer Narrative
This is a supplemental report correcting the unique device identifier (udi) information in section d4.Following the initial report submission, it was identified that the udi information initially provided was incorrect.

• Brand Name: GLIDESCOPE VIDEO BATON 2.0 LARGE
• 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: 18131651
• Report Number: 9615393-2023-00201
• Device Sequence Number: 7753242
• Product Code: CCW
• UDI-Device Identifier: 00879123006561
• UDI-Public: (01)00879123006561(11)230822
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 10/16/2023

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: 0570-0382
• Device Catalogue Number: 0570-0398
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/14/2023
• Supplement Report FDA Received Date: 07/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2023
• 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