MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE CORE SMART CABLE; LARYNGOSCOPE, RIGID

Model Number 0600-0783

Device Problems Erratic or Intermittent Display (1182); Display or Visual Feedback Problem (1184); Poor Quality Image (1408)

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

Event Date 03/11/2024

Event Type  malfunction  

Event Description

A customer reported that during a patient procedure, using a glidescope core smart cable, the screen on the connected glidescope core 15-inch monitor was intermittently turning black while they were intubating.The procedure was completed using a backup device which was made readily available.No delay in the procedure or harm to the patient was reported.Following the reported event, a verathon clinical specialist evaluated the customer's glidescope core system and was able to replicate image issues which lost clear image and created a green tinted, pixelated image.The issue was isolated to just the glidescope core smart cable.

Manufacturer Narrative

A replacement glidescope core smart cable was provided to the customer and the reported glidescope core smart cable used during the reported event was returned to verathon for evaluation.A verathon technical service representative evaluated the returned smart cable and was able to confirm the reported cable failure.When connected the smart cable to known, good, test verathon equipment, it produced a split image.Manipulating the connection between the smart cable and the test imaging device caused the image to flicker and cut out entirely.The customer's smart cable failed verathon's device functionality testing.Upon completion of verathon's device evaluation, the customer's smart cable was scrapped due to already being replaced and there being no repairs available for the device.Corrective action is not required at this time.Verathon will continue to monitor for trends.

• Brand Name: GLIDESCOPE CORE SMART CABLE
• 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: 19024228
• MDR Text Key: 339209554
• Report Number: 9615393-2024-00054
• Device Sequence Number: 1
• Product Code: CCW
• UDI-Device Identifier: 00879123006509
• UDI-Public: 010087912300650911220913
• 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,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/12/2024

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
• Device Operator: Health Professional
• Device Model Number: 0600-0783
• Device Catalogue Number: 0800-0602
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/12/2024
• Initial Date FDA Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/13/2022
• 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