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)

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

Event Date 03/13/2024

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 10-inch monitor froze during intubation.The monitor was rebooted; however, the attached laryngoscope was not detected.No delay in the procedure, use of a backup device, or harm to the patient was reported.

Manufacturer Narrative

The customer's glidescope core smart cable was returned to verathon for evaluation along with the core 10-inch monitor used during the reported event.A verathon technical service representative (tsr) evaluated the returned smart cable and was able to confirm the reported failure.The cable passed visual inspection; however, when connected to known, good, test verathon equipment, no image was produced and manipulating the connection between the smart cable and test imaging device caused the test monitor to cease recognizing the imaging device.The customer's smart cable failed verathon's device functionality testing.Next, the verathon tsr evaluated the returned glidescope core 10-inch monitor but was unable to confirm the reported image issue.The device passed verathon's visual inspection and device functionality testing.The issue was isolated to the glidescope core smart cable.Upon completion of verathon's device evaluation, both the smart cable and monitor were returned to the customer along with informing the distributor of verathon's device evaluation findings and the recommendation to replace the faulty smart cable.Corrective action is not required at this time.Verathon will continue to monitor for ongoing 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: 19088953
• MDR Text Key: 340622604
• Report Number: 9615393-2024-00055
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/15/2024

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: 03/27/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2024
• Initial Date FDA Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2020
• 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