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

Catalog Number	ENVISIO-SYS
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	03/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Although the subject device was not returned, the company conducted a complaint investigation.The complaint investigation confirmed that two pink smartclips were placed in the patient.The envisio navigation system is unable to provide reliable solutions for two same color clips since smartclips of the same color operate at the same frequency.As stated in the labeling, the envisio navigation system should not be used with two same color clips.During the case, the surgeon was advised by elucent medical to use an alternate method such as ultrasound to remove one smartclip, then they could use the envisio navigation system to remove the second smartclip.The surgeon chose to proceed with the envisio navigation system for the removal of both smartclips.
Event or Problem Description
During a case using the envisio¿ navigation system, it was reported that two 'pink' smartclips were implanted in the same patient.This event coincided with excess tissue removal from the patient.(smartclip soft tissue markers are available in three different versions, pink, green and purple.The smartclip versions are identical in materials of construction, but are differentiated by different frequencies they emit when localized by the envisio navigation system).

• Brand Name: ENVISIO NAVIGATION SYSTEM
• Common Device Name: ENVISIO NAVIGATION SYSTEM
• Manufacturer (Section D): ELUCENT MEDICAL, INC.; 6509 flying cloud drive; suite 160; eden prairie MN 55344 3307
• Manufacturer (Section G): ELUCENT MEDICAL, INC.; 6509 flying cloud drive; suite 160; eden prairie MN 55344 3307
• Manufacturer Contact: derik larson ; 6509 flying cloud drive; suite 160; eden prairie 55344-3307 ; 6519468902
• MDR Report Key: 19197641
• Report Number: 3014653199-2024-00001
• Device Sequence Number: 8321249
• 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

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/26/2024
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 26 YR
• Patient Sex: Female