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

Catalog Number	ENVISIO-SYS
Medical Device Problem Codes	Erratic or Intermittent Display (1182); Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	09/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
During a case using the envisio¿ navigation system, it was reported that the system navigation was slow or lagging.This event coincided with excess tissue removal from the patient.
Additional Manufacturer Narrative
Although the subject device was not returned, the company conducted a complaint investigation including a physical inspection of the device and use environment at its location.The complaint investigation determined that a malfunctioning electronic device (from a separate manufacturer) was emitting a unique electronic noise which interfered with the envisio navigation system for approximately 2.5 minutes.The effect of this interference was erratic navigational information displayed by the envisio navigation system for the 2.5 minutes of interference as the envisio navigation system software responded to the presence of this electronic noise.Elucent notified the customer of the malfunctioning equipment.

• 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: judson guericke ; 6509 flying cloud drive; suite 160; eden prairie, MN 55344-3307 ; 6517288855
• MDR Report Key: 17789290
• Report Number: 3014653199-2023-00002
• Device Sequence Number: 7750261
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/20/2023

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: ENVISIO-SYS
• Device Lot Number: N/A
• 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: Not provided
• Initial Report FDA Received Date: 09/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2022
• 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 Sex: Female