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); Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported that during an emergency care procedure, using a glidescope spectrum single-use lopro s3 laryngoscope, the screen on the connected glidescope core monitor became dark and green with very poor resolution.They reported the image flickered between a dark/green fuzzy view and a normal view.The procedure was able to be completed with the reported glidescope spectrum single-use lopro s3 laryngoscope.Following the procedure, the customer reported isolating the issue to the faulty larygnoscope.No delay in the procedure or harm to the patient were reported.
Additional Manufacturer Narrative
The device return is anticipated, however; at the time of the report the device has not been received by verathon.Verathon continues to investigate the reported event and a supplemental report will be submitted in accordance with 21 cfr 803.56 when additional information becomes available.
Additional Manufacturer Narrative
The reported glidescope spectrum single-use lopro s3 laryngoscope was returned to verathon for evaluation.A verathon technical service representative (tsr) evaluated the returned device but was unable to confirm the reported image issue.When connected to known, good, test verathon equipment, the blade and its light-emitting diode (led) functioned as normal.Upon visual inspection, the connector was confirmed to be in good condition and no physical damage was observed.The glidescope spectrum single-use lopro s3 passed verathon's device functionality testing.Upon completion of verathon's device evaluation, the customer was notified of the evaluation findings and was requested to return the monitor and cable used during the reported procedure for further investigation.To date, no response has been received from the customer.No further investigation is required at this time.Verathon will continue to monitor for trends.

• 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: 16854177
• Report Number: 9615393-2023-00077
• Device Sequence Number: 7529239
• Product Code: CCW
• UDI-Device Identifier: 10879123006223
• UDI-Public: 011087912300622310GT8604117250525
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2023

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: 05/25/2025
• Device Model Number: 0574-0194
• Device Catalogue Number: 0270-0938
• Device Lot Number: GT86041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2023
• Supplement Date Received by Manufacturer: 06/01/2023
• Initial Report FDA Received Date: 05/02/2023
• Supplement Report FDA Received Date: 06/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2022
• 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