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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no injury reported with this event.Use of the envisio navigation system requires the use of x-ray riser stands on the surgical bed.For patient comfort, the envisio navigation systems include a patient pad transition cushion which is intended to fit between the risers on both the back and seat sections of the surgical bed.When the back portion of the skytron bed (model series 3600, 6500, 6600 and 6700) is inclined greater than 40 degrees in the vertical position, the envisio patient pad transition cushion is compressed between the risers.This compression may result in enough back-pressure to force disassociation of the back section of some skytron beds.
Event or Problem Description
During a case which was setup with the envisio navigation system, it was reported that the skytron 6702 or bed was inclined to a near vertical position.As the back section of the or bed inclined a component of the envisio navigation system, the envisio patient pad transition pad was compressed between the x-ray risers on the back and seat sections of the or bed.The compression of the patient pad transition cushion caused sufficient back pressure to cause the back portion of the skytron or bed became disassociated from the bed frame.There was no reported patient injury resulting from this event.Elucent is filing this report due to the potential for injury.

• 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: sheryl o'brien ; 6509 flying cloud drive; suite 160; eden prairie 55344-3307 ; 3202607329
• MDR Report Key: 20697053
• Report Number: 3014653199-2024-00002
• Device Sequence Number: 3714503
• Product Code: NEU
• UDI-Device Identifier: 00851674008034
• UDI-Public: 00851674008034
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Health Professional
• Initial Reporter Occupation: Risk Manager
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 11/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2024
• Initial Report FDA Received Date: 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2024
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3014653199-12022024-001-
• Patient Sequence Number: 1
• Patient Sex: Female