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

Model Number	SYS-4000
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The sys-4000 was plugged into a wall outlet when the tower was rolled into the operating room for set up.The site started the procedure with an olympus bf-p190 scope and registered with forceps.After navigating out to the target and trying to sample unsuccessfully, they switched to a spin vision 4.0 scope 2.0 working channel.When the scope was plugged in, it was just displaying a black image (no picture was being shown).They opened another spin vision scope and the issue persisted.They were not able to get the system 4000 to work again and tried to sample blindly before moving on with the case.The veran navigated portion of the procedure was discontinued.The physician performed a broncheoalveolar lavage (bal).The procedure was able to be completed after a 30-minute delay.Although there was no impact on the patient, this event is being reported due to the 30-minute delay while the patient was under anesthesia.
Additional Manufacturer Narrative
The device was not returned for evauation.Since multiple spin vision scopes were tried and still only showed a black screen, the spin vision processor (sys-5100) is most likely the system at fault.The corrective action is to reset the processor.However, a definitive root cause could not be determined.Veran will continue to monitor field performance for this device.This event is being reported as a corrective action following a retrospective review of complaints in response to an observation from an external inspection.
Additional Manufacturer Narrative
This report is being supplemented to correct information provided in the initial medwatch report and to provide additional information.This event was initially categorized as both an adverse event and a product problem.On further review, it was determined that this event was an adverse event due to the 30-minute delay and not a reportable malfunction.Based on the investigation, since multiple spin vision scopes were tried and still only showed a black screen, the spin vision processor (sys-5100) was most likely at fault, which, in this instance, was in-use with the spin thoracic navigation system (sys-4000).Based on the risk documentation, the severity of the hazard is considered to be minor.Other than the 30-minute delay, there was no impact or injury to the patient or user as a result of 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: 17242481
• Report Number: 3007222345-2023-00063
• Device Sequence Number: 17867066
• Product Code: JAK
• UDI-Device Identifier: 00815686020101
• UDI-Public: 00815686020101
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: SYS-4000
• Device Catalogue Number: SYS-4000
• 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: 05/26/2022
• Supplement Date Received by Manufacturer: 08/15/2023
• Initial Report FDA Received Date: 06/30/2023
• Supplement Report FDA Received Date: 08/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2020
• 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: BF-P190 EVIS EXERA III BRONCHOVIDEOSCOPE.; INS-7100 SPIN VISION SCOPE, 4.0MM OD, 2.0MM WC.; SYS-5100 SPIN VISION VIDEO PROCESSOR.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown