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

Model Number	SFT-0010
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The physician called in to veran technical support (vsupport) for troubleshooting because he was having issues exporting the plan from the laptop to the tower of the sys-3000.Vsupport was able to remote into the planning station.The physician was trying to export the plan via veran usb.When the export page appeared, it would begin to export and then stop at 66% and an error message, "there was an error archiving the data.Please re-insert the drive and try again" appeared.Troubleshooting was performed, which was unsuccessful.Vsupport then attempted to transfer the information via spinlink, but spinlink continued to receive a yellow caution symbol instead of a green one.Various troubleshooting steps were performed.All attempts to export were made with the veran usb and a usb the site had, both received the error message and stopped loading at 66%.After asking the physician if usb transfer is allowed at this site, he said "this is how we normally do it but it is always messing with the computer and may have put a block on the usb transfer".The procedure was scheduled as a davinci right upper lobe (rul) wedge resection with navigational marking of the rul lung lesion with dye.The procedure was reportedly completed using traditional methods of lesion marking.There was a procedure delay of 40 minutes while troubleshooting was being performed, during which the patient was under anesthesia.Other than the prolonged procedure time, it was confirmed there was no impact on the patient due to the reported issues.Since the reported event, it was confirmed that the site successfully completed a navigated procedure with no issues.The device performed as intended.
Additional Manufacturer Narrative
D4: software 4.3.2.The investigation is still in progress.If additional information is received, this report will be supplemented accordingly.
Additional Manufacturer Narrative
This report is being supplemented to correct information provided in the initial medwatch report.Correction to b4: date of this report of the initial report was 05-jun-2023, not 04-jun-2023.Since it was confirmed that the site successfully completed a navigated procedure with no issues after the reported event, a root cause of the reported issue could not be determined.

• Brand Name: SPIN PLANNING LAPTOP SOFTWARE APPLICATION
• 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 dr; saint louis, MO 63114 ; 3146598500
• MDR Report Key: 17057228
• Report Number: 3007222345-2023-00025
• Device Sequence Number: 12495431
• Product Code: JAK
• UDI-Device Identifier: 00815686021085
• UDI-Public: 00815686021085
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2023

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
• Operator of Device: Health Professional
• Device Model Number: SFT-0010
• Device Catalogue Number: SFT-0010
• 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: 05/05/2023
• Supplement Date Received by Manufacturer: 12/28/2023
• Initial Report FDA Received Date: 06/05/2023
• Supplement Report FDA Received Date: 12/28/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SYS-0185 SPIN PLANNING LAPTOP WORKSTATION; SYS-3000 IG4 SYSTEM, 120V, 60HZ
• Outcome Attributed to Adverse Event: Other
• Patient Age: 61 YR
• Patient Sex: Female