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

Catalog Number	NAV-SLIM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	08/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Although the subject device was not returned, the company conducted a complaint investigation.In addition, a company field representative was present at the case.The complaint investigation determined that the navslim was communicating successfully from the time it was discovered that separation had occurred to the time it was replaced with a new navslim.Even though the company was not able to establish a connection between the separation of the navslim and the excess tissue removal, the company is submitting this mdr in an abundance of caution to ensure full compliance with 21 cfr part 803.
Event or Problem Description
During a case using the envisio¿ navigation system, it was reported that the navslim component became separated from the electrocautery tool.A new navslim was connected.This event coincided with excess tissue removal from the patient.

• Brand Name: ENVISIO NAVIGATION SYSTEM
• Common Device Name: ENVISIO NAVIGATION SYSTEM NAVSLIM
• 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: judson guericke ; 6509 flying cloud drive; suite 160; eden prairie, MN 55344-3307 ; 6517288855
• MDR Report Key: 17761082
• Report Number: 3014653199-2023-00001
• Device Sequence Number: 15227590
• Product Code: NEU
• UDI-Device Identifier: 00851674008072
• UDI-Public: 00851674008072
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 09/15/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/21/2025
• Device Catalogue Number: NAV-SLIM
• Device Lot Number: 13761
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2023
• Initial Report FDA Received Date: 09/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2023
• Is the Device Labeled for Single Use? (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: Other
• Patient Age: 22 YR
• Patient Sex: Female