MAUDE Adverse Event Report: VERAN MEDICAL TECHNOLOGIES, INC. SPIN THORACIC NAVIGATION SYSTEM, 120V, 60HZ

Model Number	SYS-4000
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A veran representative contacted veran customer support (vsupport) on behalf of the user and reported that the sys-4000 would not turn on when the system was powered on.The system had to be opened up and the power button on the central processing unit (cpu) had to be pressed to turn the system on.There was no reported patient or user harm.
Additional Manufacturer Narrative
The subject device was returned to the manufacturer for evaluation.The repair center confirmed the device would not turn on using the external power button and the cpu was not functioning properly.The cpu and necessary cables were replaced to address the issue.The device was confirmed to be working as expected and passed all testing.This event is being reported as a corrective action following a retrospective review of complaints in response to an observation from an external inspection.Note that this report is intentionally being designated as medwatch number 3007222345-2024-00500.This report is being submitted via the esg portal/webtrader, rather than through an electronic database that utilizes an automatic numbering system.So that this report will not conflict with any future automatically generated medwatch report numbers, we are using '-00500' as the starting point for any reports being submitted through the esg portal/webtrader.

• Brand Name: SPIN THORACIC NAVIGATION SYSTEM, 120V, 60HZ
• 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 ; 3146598560
• MDR Report Key: 18689270
• Report Number: 3007222345-2024-00500
• Device Sequence Number: 15264728
• Product Code: JAK
• UDI-Device Identifier: 00815686020101
• UDI-Public: 00815686020101
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 02/12/2024

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 Model Number: SYS-4000
• Device Catalogue Number: SYS-4000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2021
• Initial Report FDA Received Date: 02/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2021
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown