MAUDE Adverse Event Report: ELUCENT MEDICAL ENVISIO SYSTEM

Model Number	ENVISIO-SYS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer review was completed based on available complaint information and system case logs, as the system remained at the customer site and was not physically evaluated.Review of the case logs, including setup, calibration, self-test results, navigation data, potential interference indicators, and complaint history, did not identify evidence of system malfunction or inaccuracy.The logs indicated the user navigated to or near the smartclip during the surgical excisions.Based on the available information, the reported system inaccuracy could not be confirmed.
Event or Problem Description
During a lumpectomy procedure, the physician reported a discrepancy between the expected clip location and the system-indicated location.Initial specimens did not include the clip; the clip was retrieved in a subsequent excision.The physician reported the final specimen was larger than initially planned.

• 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 Contact: sheryl o'brien ; 6509 flying cloud dr; suite 160; eden prairie, MN 55344-3307 ; 7725391226
• MDR Report Key: 25034309
• Report Number: 3014653199-2026-00002
• Device Sequence Number: 21162926
• Product Code: NEU
• UDI-Device Identifier: 00851674008553
• UDI-Public: (01)00851674008553
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/29/2026

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: 04/01/2026
• Initial Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2025
• 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: Unknown