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

Model Number	0570-0420
Medical Device Problem Codes	Erratic or Intermittent Display (1182); Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that during a patient procedure, using a glidescope video baton quickconnect large, the picture on the connected glidescope core 10-inch monitor freezes when the glidescope core quickconnect cable and video baton are moved.No delay in the procedure, use of a backup device, or harm to the patient was reported.
Additional Manufacturer Narrative
A replacement glidescope video baton quickconnect large was provided to the customer and the reported glidescope video baton quickconnect large was returned to verathon for evaluation along with the core 10-inch monitor and glidescope core quickconnect cable used during the reported event.A verathon technical service representative evaluated the returned devices and was able to confirm the reported image issue.When connecting the video baton to verathon's test equipment, the image cuts out when adjusting the flexible tube.Furthermore, visual inspection identified that the camera housing was detached from the flexible tube and the camera lens was cracked.The customer's video baton failed verathon's device functionality testing.Next, the customer's glidescope core quickconnect cable was evaluated and passed visual inspection; however, when connected to verathon's test equipment, the image cuts out when manipulating the cable.The customer's quickconnect cable failed verathon's device functionality testing.Next, the customer's glidescope core 10-inch monitor was evaluated and passed visual inspection.The monitor produced a normal image when connected to all test equipment and no failures were observed during testing.The customer's monitor passed verathon's device functionality testing and confirmed to be within specification.Upon completion of verathon's device evaluation, both the customer's video baton and quickconnect cable were scrapped due to the customer already being provided replacements and there being no repairs available for the devices.The monitor was returned to the customer.Corrective action is not required at this time.Verathon will continue to monitor for trends.Upon review of the device history for the video baton serial number (b)(6), it was determined that the device was manufactured on december 8, 2021 and is past the two (2) year expected product life as outlined in the glidescope video laryngoscopes operations and maintenance manual (omm).It is likely that the age of the device, two (2) years and eight (8) months, may have caused or contributed to the event.Furthermore, the 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.Reference the attached corresponding report containing the device information, event details and evaluation findings for the customer's returned glidescope core quickconnect cable that was confirmed to have contributed to the reported event.

• 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: 20182304
• Report Number: 9615393-2024-00112
• Device Sequence Number: 20898193
• Product Code: CCW
• UDI-Device Identifier: 00879123007797
• UDI-Public: (01)00879123007797(11)211208
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 08/14/2024

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: 0270-1058
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2024
• Initial Report FDA Received Date: 09/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2021
• 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