MAUDE Adverse Event Report: ELUCENT MEDICAL ENVISIO SYSTEM

Catalog Number	ENVISIO-SYS
Medical Device Problem Codes	Device Sensing Problem (2917); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Blister (4537)
Date of Event	01/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during navigation, the envisio system was not consistently displaying navigation to the targeted clip.After the case was concluded, the grounding pad was found to be overlapping the patient pad.When the grounding pad was removed, a blister was found on the patient beneath where the grounding pad was placed.
Additional Manufacturer Narrative
In a review of the clinical case, the presence of the grounding pad above the envisio patient pad was confirmed.Testing confirmed that a grounding pad positioned above the patient pad may result in compromised navigation.It was also confirmed that depending on the location above the patient pad, the grounding pad may heat and could result in tissue damage.Both the operating manual and patient pad decal have instructions to place all grounding pads footward away from the patient pad.Based on the potential to have compromised navigation, there was no device malfunction determined to occur based on the reported information.This is the only reported case of device-to-device interaction with a grounding pad in over 18,000 clinical cases with the envisio system.

• Brand Name: ENVISIO SYSTEM
• Common Device Name: ENVISIO
• Manufacturer (Section D): ELUCENT MEDICAL; 6509 flying cloud drive; suite 160; eden prairie MN 55344 3307
• Manufacturer (Section G): ELLUCENT MEDICAL; 6509 flying cloud drive; suite 160; eden prairie MN 55334 3307
• Manufacturer Contact: sheryl o'brien ; 6509 flying cloud drive; suite 160; eden prairie, MN 55334-3307 ; 8444177400
• MDR Report Key: 21268651
• Report Number: 3014623199-2023-00001
• Device Sequence Number: 18252696
• Product Code: NEU
• UDI-Device Identifier: 00851674008034
• UDI-Public: 00851674008034
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K183400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Relabeling
• Type of Report: Initial
• Report Date (Section B): 01/29/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: ENVISIO-SYS
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2025
• Initial Report FDA Received Date: 01/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/20/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability
• Patient Sex: Female