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

Model Number	ENVISIO-SYS
Medical Device Problem Codes	Use of Incorrect Control/Treatment Settings (1126); Malposition of Device (2616); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	05/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The system was used to localize and guide excision of a lesion marked with three clips.Imaging performed after placement showed that the clips were positioned outside the lesion.During surgery, two clips were bracketed and used to guide tissue excision.Only one clip was recovered in the specimen, and the target lesion was not present.A second surgical procedure was required to remove the remaining clips and excise the lesion.A review of the case logs confirmed that the system performed as intended, accurately guiding removal of the targeted clip.Because the clips were located outside the lesion, the second and third clips were not subsequently selected for navigation.
Event or Problem Description
Three clips were implanted to localize a target.Post-implant imaging revealed all three clips to be positioned outside of the lesion.During the subsequent surgical procedure, two clips were bracketed to guide tissue excision.Upon removal of the localized specimen, only one clip was confirmed within the excised tissue.The remaining two clips were not retrieved, necessitating a second surgical excision to locate and remove the residual markers and the target lesion.

• Brand Name: ENVISIO SYSTEM
• Common Device Name: ENVISIO
• Manufacturer (Section D): ELUCENT MEDICAL, INC.; 6509 flying cloud drive suite; suite 160; eden prairie MN 55344 3307
• Manufacturer (Section G): ELUCENT MEDICAL, INC.; 6509 flying cloud drive; suite 160; eden praire MN 55344 3307
• Manufacturer Contact: sheryl o'brien ; 6509 flying cloud drive; suite 160; eden prairie, MN 55344-3307 ; 8447177400
• MDR Report Key: 22181430
• Report Number: 3014653199-2025-00003
• Device Sequence Number: 15625844
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/10/2025

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: 05/15/2025
• Initial Report FDA Received Date: 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2024
• 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