MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE SPECTRUM SINGLE-USE LOPRO S3; 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	03/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A replacement glidescope spectrum single-use lopro s3 laryngoscope was provided to the customer and the reported single-use lopro s3 laryngoscope used during the procedure was returned to verathon for evaluation.A verathon technical service representative (tsr) evaluated the returned single-use lopro s3 laryngoscope and was able to confirm the reported image failure.When connecting the reported single-use lopro s3 laryngoscope to known, good, test verathon equipment, the tsr observed that the blade produced a pixelated image.The customer's single-use lopro s3 laryngoscope failed verathon's device functionality testing.Upon completion of the evaluation, the device was scrapped, due to the customer already being provided a replacement.Corrective action is currently not required at this time.Verathon will continue to monitor for any ongoing trends.
Event or Problem Description
A customer reported that during an emergency care procedure, using a glidescope spectrum single-use lopro s3 laryngoscope, the image glitched and the screen was split in half before it turned black.The customer reported a delay when a different glidescope system was brought into the room.The same blade was used before switching to a new blade; however, it was discovered that the issue was isolated to the initial blade.The new disposable blade was used to complete the operation and the patient was quickly intubated.No harm to the patient was reported.

• Brand Name: GLIDESCOPE SPECTRUM SINGLE-USE LOPRO S3
• 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: 16583657
• Report Number: 9615393-2023-00052
• Device Sequence Number: 20007212
• Product Code: CCW
• UDI-Device Identifier: 10879123006223
• UDI-Public: 011087912300622310JE1279571117250120
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 03/01/2023

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 Expiration Date: 01/20/2025
• Device Model Number: 0574-0194
• Device Catalogue Number: 0270-0938
• Device Lot Number: JE12795711
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2023
• Initial Report FDA Received Date: 03/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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