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

Model Number 0574-0194

Device Problems No Display/Image (1183); Display or Visual Feedback Problem (1184)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/17/2023

Event Type  malfunction  

Manufacturer Narrative

A replacement glidescope spectrum single-use lopro s3 laryngoscope was provided to the customer and the reported glidescope single-use lopro s3 laryngoscope used during the procedure was returned to verathon for evaluation.A verathon technical service representative (tsr) evaluated the returned device and was unable to confirm the reported failure.When connected to known, good, test verathon equipment, normal image was obtained and the light was functional.The tsr manipulated the connection to the cable and it did not cause any image issues.Furthermore, the tsr reconnected the blade 10 times and it was recognized each time and displayed an image as intended.The customer's single-use lopro s3 laryngoscope passed verathon's device functionality testing with no failures found.Upon completion of the evaluation, the customer was notified about verathon's device evaluation findings and recommended re-checking the cable and monitor used with the glidescope spectrum single-use lopro s3 laryngoscope.To date, no further information has been made available to verathon from the customer.No further investigation is required at this time.Verathon will continue to monitor for any ongoing trends.

Event Description

A customer reported that during a patient procedure, using a glidescope spectrum single-use lopro s3 laryngoscope, the image was lost on the connected monitor.The customer reported isolating the issue to the laryngoscope.No delay in the procedure, use of a backup device, or harm to the patient was reported.

• Brand Name: GLIDESCOPE SPECTRUM SINGLE-USE LOPRO S3
• Type of Device: 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: 17798552
• MDR Text Key: 324048903
• Report Number: 9615393-2023-00185
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0574-0194
• Device Catalogue Number: 0270-0938
• Device Lot Number: GT93705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2023
• Date Manufacturer Received: 08/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1