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

Model Number	SYS-4000
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A veran representative went on-site to perform troubleshooting on sept.13, 2022, and again on oct.5, 2022.After the veran representative replaced the dvi to dvi cable with a dvi cable provided by the hospital, the reported issue (static/sparkling on the screen) did not occur.The veran representative tested the system with the original cable and the issue occurred again.Once the hospital-provided dvi cable was re-installed, the issue was resolved.Research and development at veran performed testing with five sys-5100 (spin vision video processor) and two lots of dvi to dvi cable.The static/sparkling image was replicated across all dvi cables and sys-5100 combinations.It was determined the issue only occurred when single-use bronchoscopes were used with the sys-4000 that are configured with an sys-5100.At that time, it was determined that an incorrect dvi cable had been supplied.Replacing the incorrect dvi cable with the correct dvi cable resolved the video quality issues.A subsequent recall was initiated for the replacement and return of the incorrect dvi cables.This event is being reported in response to an observation from an external inspection.There has been no associated harm attributed to the reported event.We will continue to monitor and trend similar incidents.
Event or Problem Description
The customer reported that during a procedure set-up in the endoscopy suite, after the doctor plugged an ins-7130 (spin vision single-use flexible bronchoscope) into the sys-5100 (spin vision processor), which is a component of the sys-4000 (spin thoracic navigation system), the image was showing static/sparkling on the screen.White balancing and cfs were pressed a few times to try and correct the issue.The bronchoscope was unplugged and re-plugged without success to correct the image issue.There was a 10-minute delay in the procedure, however the intended navigated procedure was reportedly completed.There was no impact on the patient due to the delay or the reported issue.

• 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: 16549615
• Report Number: 3007222345-2023-00015
• Device Sequence Number: 6491196
• Product Code: JAK
• UDI-Device Identifier: 00815686020101
• UDI-Public: 00815686020101
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 03/15/2023

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: 08/23/2022
• Initial Report FDA Received Date: 03/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2022
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1103-2023
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INS-7130 SPIN VISION SINGLE-USE FLEXIBLE BRONCHOSC.; SYS-5100 SPIN VISION PROCESSOR.
• Patient Sex: Unknown