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

Model Number	0570-0417
Medical Device Problem Codes	Erratic or Intermittent Display (1182); Display or Visual Feedback Problem (1184); Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported glidescope video baton quickconnect large was returned to verathon for evaluation along with the customer's glidescope core 2m quickconnect cable.A verathon technical service representative (tsr) evaluated the video baton and was able to confirm the reported image issue and the light-emitting diode (led) cutting in and out.In addition, visual inspection identified the video baton's connector was missing a pin.The glidescope video baton quickconnect large failed verathon's device functionality testing.Next, the verathon tsr evaluated the returned cable but was unable to reproduce the reported image issue.The glidescope core 2m quickconnect cable passed verathon's device functionality testing and was confirmed to be within specification.Upon completion of verathon's device evaluation, the glidescope video baton quickconnect large and glidescope core 2m quickconnect cable were scrapped due to the customer already being provided replacements and there being no repairs available for the device.Corrective action is not required at this time.Verathon will continue to monitor for trends.
Event or Problem Description
A customer reported that during an intubation using a glidescope video baton quickconnect large, the image was going in and out.Furthermore, the light failed to illuminate consistently and the glidescope core 2m quickconnect cable was not staying connected to the video baton.The procedure was completed using a backup device which was made available in an unspecified amount of time.No delay in the procedure 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: 21928738
• Report Number: 9615393-2025-00042
• Device Sequence Number: 9031016
• Product Code: CCW
• UDI-Device Identifier: 00879123007797
• UDI-Public: (01)00879123007797(11)250218
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 04/29/2025

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: 0570-0417
• Device Catalogue Number: 0570-0420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2025
• Initial Report FDA Received Date: 04/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2025
• 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