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

Model Number 0800-0543

Device Problems Erratic or Intermittent Display (1182); Display or Visual Feedback Problem (1184); Material Separation (1562)

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

Event Date 03/28/2024

Event Type  malfunction  

Manufacturer Narrative

The customer declined the option to have their glidescope spectrum smart cable returned to verathon for evaluation.Since the device was not returned to verathon for evaluation, the cause could not be determined.Review of complaint history for the reported smart cable serial number "(b)(6)" did not identify any previous complaints.Trending analysis for glidescope spectrum smart cables does not identify any trends exceeding acceptable limits.Review of the system risk assessment confirmed that the risk associated with the hazardous scenario has been adequately captured and characterized.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 spectrum smart cable, the screen on the connected glidescope gvm monitor intermittently blacked out during intubation.It was further reported that when they unplugged the smart cable from the laryngoscope to check the connection, the metal shield of the hdmi end of the smart cable came off and remained in the laryngoscope connector.The procedure was completed using a different glidescope gvm system 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 SPECTRUM 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: 19164542
• MDR Text Key: 340962143
• Report Number: 9615393-2024-00060
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/28/2024

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: 0800-0543
• Device Catalogue Number: 0800-0544
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2024
• Initial Date FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/31/2017
• 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