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

Model Number	0570-0420
Medical Device Problem Codes	No Display/Image (1183); Display or Visual Feedback Problem (1184); Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A replacement glidescope video baton quickconnect large was provided to the customer and the glidescope video baton quickconnect large used during the procedure was returned to verathon for evaluation.A verathon technical service representative (tsr) evaluated the returned device and was able to confirm the reported device failure.The tsr confirmed that the video baton's light was very dim.When connecting the reported video baton to known, good, test verathon equipment, the image on the connected test monitor produced a blue and blurry image.Furthermore, visual inspection found the camera housing and lens were damaged.The glidescope video baton quickconnect large failed verathon's functionality testing.The glidescope video laryngoscopes operations and maintenance manual (omm) notes, "before every use, ensure that the instrument is operating correctly and has no sign of damage.Do not use this product if the device appears damaged." verathon followed up with the customer and restated the importance of checking the device before its use in a procedure.Upon completion of verathon's device evaluation, the glidescope video baton quickconnect large was scrapped due to the customer already being provided a replacement and there being no repairs available for this device.Corrective action is not required at this time.Verathon will continue to monitor for trends.
Event or Problem Description
The customer reported that during a patient procedure, using a glidescope video baton quickconnect large, the light was dim when turned on; however, the screen went black once the video baton was inserted into the patient's airway.No delay in the procedure, use of a backup device, or harm to the patient was reported.

• Brand Name: GLIDESCOPE VIDEO BATON QUICKCONNECT 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: 19973618
• Report Number: 9615393-2024-00107
• Device Sequence Number: 7075192
• Product Code: CCW
• UDI-Device Identifier: 00879123007797
• UDI-Public: (01)00879123007797(11)231010
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 07/16/2024

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: 0570-0420
• Device Catalogue Number: 0570-0417
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2024
• Initial Report FDA Received Date: 08/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2023
• 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