MAUDE Adverse Event Report: VERAN MEDICAL TECHNOLOGIES, INC SPIN PLANNING LAPTOP WORKSTATION

Model Number	SYS-0185
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
After the veran representative cleared the procedure plan on the planning laptop and re-planned the procedure, the plan was able to exported onto the usb and successfully uploaded to the tower.No further action is necessary.
Event or Problem Description
Veran representative attempted to export the procedure plan from the spin planning workstation onto a usb and import it onto the tower.The plan would not export.The patient was under anesthesia.The procedure was delayed for 20 minutes and then had to be aborted.
Additional Manufacturer Narrative
This report is being supplemented to provide information that was inadvertently not provided in the initial medwatch report and to correct information provided in the initial report (see b3: date of event).D4: laptop software version: 4.3.0.Tower software version 4.3.2.Both are compatible with each other.G3: date received by manufacturer was blank on the initial medwatch report and should have been 09-may-2022.The device was not returned for evaluation, as troubleshooting was performed on-site and the issue was resolved.All of the relevant data for this event was deleted during troubleshooting; as such, determining the cause of the issue was not possible.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 PLANNING LAPTOP WORKSTATION
• Common Device Name: LAPTOP
• 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: 14605334
• Report Number: 3007222345-2022-00018
• Device Sequence Number: 6085532
• Product Code: JAK
• UDI-Device Identifier: 00815686020033
• UDI-Public: 00815686020033
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2023

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: SYS-0185
• Device Catalogue Number: SYS-0185
• 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: 06/06/2022
• Initial Report FDA Received Date: 06/06/2022
• Supplement Report FDA Received Date: 08/08/2023
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown