MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE SPECTRUM SINGLE-USE LOPRO S3 LARYNGOSCOPE; LARYNGOSCOPE, RIGID

Model Number	0574-0194
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	01/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported that during a patient procedure, using a glidescope spectrum single-use lopro s3 laryngoscope, the display on the connected glidescope core 15-inch monitor went black a couple of times.The procedure was completed using a backup device.No delay in the procedure or harm to the patient was reported.The customer reported that the issue was likely due to the lopro s3 not making a good connection.However, the customer's troubleshooting was unable to duplicate the issue.
Additional Manufacturer Narrative
The customer declined the option to have their glidescope spectrum single-use lopro s3 laryngoscope returned to verathon for evaluation.Since the device was not returned to verathon, the cause could not be determined.However, following the reported incident, the facility confirmed that the glidescope system was operating as intended.Since the lot number of the lopro s3 was not provided, complaint history could not be reviewed for the subject lopro s3 lot to identify if there were any previous complaints reported to verathon.Trending analysis for glidescope spectrum single-use lopro laryngoscopes does not identify any trends exceeding acceptable limits.Verathon confirmed that the risk associated with the hazardous scenario has been adequately captured and characterized per the system risk assessment.Corrective action is not required at this time.Verathon will continue to monitor for trends.

• Brand Name: GLIDESCOPE SPECTRUM SINGLE-USE LOPRO S3 LARYNGOSCOPE
• 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: 21304955
• Report Number: 9615393-2025-00018
• Device Sequence Number: 8922319
• Product Code: CCW
• UDI-Device Identifier: 00879123006226
• UDI-Public: 00879123006226
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/09/2025

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: 0574-0194
• Device Catalogue Number: 0270-0938
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2025
• Initial Report FDA Received Date: 02/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown