MAUDE Adverse Event Report: VERAN MEDICAL TECHNOLOGIES, INC. SPIN THORACIC NAVIGATION SYSTEM® (USA); COMPUTED TOMOGRAPHY X-RAY SYSTEM

Model Number	SYS-4000
Medical Device Problem Code	Loss of Power (1475)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to olympus for evaluation.The investigation is ongoing and follow-up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Event or Problem Description
The customer reported to olympus the veran spin thoracic navigation system® (usa) was powered on prior to the start of a procedure when the user noted the screens were not receiving input.After troubleshooting, it was determined the cpu was not receiving power.As a result, the veran navigation portion of the procedure had to be cancelled, but the rest of the procedure was completed as planned.There were no reports of patient harm or impact as a result of the device malfunction.
Event or Problem Description
The planned procedure was a diagnostic, navigational bronchoscopy.The users attempted to troubleshoot the device while the patient was in the room which caused a delay for an unknown amount of time.The bronchoscopy was completed without the use of the veran spin thoracic navigation system.The patient was also referred to another hospital.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information based on the information supplied by the customer and developing events.
Additional Manufacturer Narrative
Correction to the initial medwatch as the subject device will not be evaluated as this complaint is related to a product that is currently being removed from the market.Therefore, this device is being investigated under the recall associated with this product.If additional information becomes available, this report will be supplemented accordingly.

• Brand Name: SPIN THORACIC NAVIGATION SYSTEM® (USA)
• Common Device Name: COMPUTED TOMOGRAPHY X-RAY SYSTEM
• Manufacturer (Section D): VERAN MEDICAL TECHNOLOGIES, INC.; 1938 innerbelt business center drive; st.louis MO 63114
• Manufacturer (Section G): VERAN MEDICAL TECHNOLOGIES, INC.; 1938 innerbelt business center drive; st.louis MO 63114
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17715874
• Report Number: 3007222345-2023-00154
• Device Sequence Number: 2236443
• Product Code: JAK
• UDI-Device Identifier: 00815686020101
• UDI-Public: 00815686020101
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: User Facility
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/15/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2023
• Supplement Date Received by Manufacturer: 09/13/2023; 03/15/2024
• Initial Report FDA Received Date: 09/08/2023
• Supplement Report FDA Received Date: 10/04/2023; 03/15/2024
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-2659-2023
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Sex: Unknown