MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE TITANIUM LOPRO T4 REUSABLE LARYNGOSCOPE; LARYNGOSCOPE, RIGID

Model Number 0574-0127

Device Problems Display or Visual Feedback Problem (1184); Poor Quality Image (1408)

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

Event Date 10/30/2023

Event Type  malfunction  

Manufacturer Narrative

A replacement glidescope titanium lopro t4 reusable laryngoscope was provided to the customer and the reported glidescope titanium lopro t4 reusable laryngoscope used during the procedure was returned to verathon for evaluation.A verathon technical service representative evaluated the returned laryngoscope and was able to confirm the reported image issue.Upon visual inspection, the lens appeared scratched.When connected to known, good, test verathon equipment, the picture displayed poor image quality.The customer's glidescope titanium lopro t4 reusable laryngoscope failed verathon's device functionality testing.Upon completion of verathon's device evaluation, the device was scrapped due to the customer already being provided a replacement and there being no repairs available for the device.Corrective action is not required at this time.Verathon will continue to monitor for trends.

Event Description

A customer reported that during a patient procedure, using a glidescope titanium lopro t4 reusable laryngoscope, the image was dark and cloudy so that users were unable to visualize appropriately.The procedure was completed using a backup glidescope titanium lopro t4 reusable laryngoscope which was made available in an unspecified amount of time.No delay in the procedure or harm to the patient was reported.

• Brand Name: GLIDESCOPE TITANIUM LOPRO T4 REUSABLE LARYNGOSCOPE
• 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: 18131658
• MDR Text Key: 328625710
• Report Number: 9615393-2023-00206
• 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: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0574-0127
• Device Catalogue Number: 0574-0148
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1