MAUDE Adverse Event Report: ELUCENT MEDICAL, INC. ENVISIO SYSTEM

Model Number	ENVISIO-SYS
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	05/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
In a review of the clinical case, the envisio system was found to confirm the reported smartclip displacement occurred during navigation.The smartclip was confirmed to have been removed from the patient as a result of its displacement during the procedure.Based on the reported information, the displacement prevented surgical navigation resulting in a second surgical resection to be required to remove intended tissue.
Event or Problem Description
It was reported that during navigation, the smartclip was displaced from the target location.The displacement of the smartclip prevented surgical navigation resulting in incomplete removal of the target tissue.A second surgical procedure was reported to be required.

• Brand Name: ENVISIO SYSTEM
• Common Device Name: ENVISIO
• Manufacturer (Section D): ELUCENT MEDICAL, INC.; 6509 flying cloud drive; suite 160; eden praire MN 55344 3307
• Manufacturer (Section G): ELUCENT MEDICAL; 6509 flying cloud drive; suite 160; eden prairie MN 55344 3307
• Manufacturer Contact: sheryl o'brien ; 6509 flying cloud drive; suite 160; eden praire, MN 55344-3307 ; 8444177400
• MDR Report Key: 22142107
• Report Number: 3014653199-2025-00002
• Device Sequence Number: 7275976
• Product Code: NEU
• UDI-Device Identifier: 00851674008034
• UDI-Public: 00851674008034
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/04/2025

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 Model Number: ENVISIO-SYS
• Device Catalogue Number: ENVISIO-SYS
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2025
• Initial Report FDA Received Date: 06/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female