MAUDE Adverse Event Report: VERAN MEDICAL TECHNOLOGIES, INC. SPIN THORACIC NAVIGATION SYSTEM

Model Number	SYS-4000
Medical Device Problem Code	Device Emits Odor (1425)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Further discussions determined the smell could be due to a loose wire, the uninterruptible power supply (ups) box, or the battery.Veran will continue to monitor field performance for this device.This event is being reported as a corrective action following a retrospective review of complaints in response to an observation from an external inspection.
Event or Problem Description
The facility reported that after the procedure was completed, the staff noticed that the system smelled of smoke.A veran representative went on-site on (b)(6) 2021, to troubleshoot and found that the smell was coming from the central processing unit (cpu) in the system.There was no impact or injury to the patient or the procedure.

• Brand Name: SPIN THORACIC NAVIGATION SYSTEM
• Common Device Name: NAVIGATION SYSTEM
• Manufacturer (Section D): VERAN MEDICAL TECHNOLOGIES, INC.; 1938 innerbelt business center; saint louis MO 63114
• Manufacturer (Section G): VERAN MEDICAL TECHNOLOGIES, INC.; 1938 innerbelt business center; saint louis MO 63114
• Manufacturer Contact: jennifer andre ; 1938 innerbelt business center; saint louis, MO 63114 ; 3146598500
• MDR Report Key: 17242497
• Report Number: 3007222345-2023-00065
• Device Sequence Number: 6708314
• Product Code: JAK
• UDI-Device Identifier: 00815686020101
• UDI-Public: 00815686020101
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K170023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/30/2023

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 Model Number: SYS-4000
• Device Catalogue Number: SYS-4000
• 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: 05/25/2021
• Initial Report FDA Received Date: 06/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2017
• 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
• Patient Sex: Unknown