MAUDE Adverse Event Report: ELUCENT MEDICAL ENVISIO SYSTEM

Model Number	ENVISIO-SYS
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer review included analysis of system event history logs, which confirmed the initially implanted clip was briefly detected during the initial procedure setup but was not subsequently recognized by the system.During the second procedure, localization and excision were successfully completed using a newly implanted clip.The clips were not returned for evaluation despite request; therefore, no functional testing could be performed.The malfunction was verified through log review; however, a definitive root cause could not be established.Review of historical complaint data did not identify a related trend.No adverse clinical signs or symptoms were reported.The event required an additional surgical procedure to complete lesion removal.
Event or Problem Description
A localization clip was implanted to mark a target lesion prior to surgical excision.During the subsequent procedure, the system briefly detected the clip but was unable to maintain localization, and the procedure could not be completed as intended.The patient later underwent a second procedure during which an additional clip was implanted to facilitate localization and excision.The lesion was successfully removed.Pathology confirmed both clips were present in the excised specimen.The devices were not returned for evaluation.

• Brand Name: ENVISIO SYSTEM
• Common Device Name: ENVISIO
• Manufacturer (Section D): ELUCENT MEDICAL; 6509 flying cloud drive; suite 160 MN 55344 3307
• Manufacturer Contact: sheryl o'brien ; 6509 flying cloud drive; suite 160; eden prairie, MN 55344-3307 ; 8444177400
• MDR Report Key: 24408347
• Report Number: 3014653199-2026-00001
• Device Sequence Number: 8223401
• Product Code: NEU
• UDI-Device Identifier: 00851674008034
• UDI-Public: (01)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): 01/23/2026

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: 01/23/2026
• Initial Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female