MAUDE Adverse Event Report: VERAN MEDICAL TECHNOLOGIES, INC SPIN DRIVE SOFTWARE

Model Number	SFT-0011
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
With a patient under anesthesia, and due to a connectivity issue, the procedure was aborted.
Additional Manufacturer Narrative
The site called in because spin link was not working.Spin link is the process by which the physician moves the patient information from the planning software to the drive software, to begin the procedure.The site has all usbs blocked, therefore spin link is the only option.The staff would not facetime with vsupport to aid in the troubleshooting and the corporate offices were closed.Vsupport was unable to remote in or see anything going on in the room.Vsupport asked the staff to confirm that the planning station and tower were connected to the network and they confirmed that the planning laptop was on the network, but the tower was not.Vsupport asked if they use internet or wifi and they responded wifi.There was no it on site.Vsupport asked several times if the site usually plugged in a blue cord to the connect to the network (blue cord would be to hardwire the tower to the network) and they responded no.The site attempted to unblock usbs on the laptop, but were unsuccessful.The patient was put under before the issue arose (before the plan was uploaded to the drive software) and since they were unable to fix the connectivity issue quickly, they decided to wake the patient up and abort the procedure.The site representative came to the site the next day and once he plugged the internet cable (blue cord) into the tower, the rep was able to transfer the plan from the laptop to the tower via spin link with no issues.This was determined to be user error and the site representative communicated the issue and resolution to the team.
Additional Manufacturer Narrative
This report is being supplemented to provide information that was inadvertently not included in the initial medwatch report and to provide the results of the investigation of the event.G3: date received by manufacturer was blank in the initial medwatch submission and should have been 21-feb-2022.The conclusion of the investigation is that the site did not have the tower connected to the network via ethernet cable, which is how the system is configured to communicate with the planning station.In subsequent procedures, the site has connected the system via ethernet and everything has worked as expected.There was no malfunction of any veran device.Veran will continue to monitor field performance for this device.This supplemental report is being submitted as a corrective action following a retrospective review of complaints in response to an observation from an external inspection.

• Brand Name: SPIN DRIVE SOFTWARE
• Common Device Name: SOFTWARE
• 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: 13770727
• Report Number: 3007222345-2022-00013
• Device Sequence Number: 11788392
• Product Code: JAK
• UDI-Device Identifier: 00815686021078
• UDI-Public: 00815686021078
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2023

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
• Device Model Number: SFT-0011
• Device Catalogue Number: SFT-0011
• Device Lot Number: 4.3.0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 04/21/2022
• Initial Report FDA Received Date: 03/15/2022
• Supplement Report FDA Received Date: 08/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown