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	Wireless Communication Problem (3283)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported to olympus the spin thoracic navigation system was being used during a dye marking localization procedure prior to a laparoscopic biopsy when the image and instrument were being shown on screen to move erratically despite the device remaining stationary.Another always-on tip tracked needle was used but displayed the same problem during device registration.Because the navigation could not be used, the procedure was cancelled after 30 minutes of the patient being under anesthesia with plans to complete the biopsy via a cone-beam ct and a laparotomy procedure.Despite the procedural delay and changed plan, there was no harm to the patient reported.
Additional Manufacturer Narrative
The device was not returned to olympus for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
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: 17568418
• Report Number: 3007222345-2023-00152
• Device Sequence Number: 15117737
• Product Code: JAK
• UDI-Device Identifier: 00815686020101
• UDI-Public: 00815686020101
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: SYS-4000
• Device Lot Number: 84247190530
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2023
• Supplement Date Received by Manufacturer: 03/15/2024
• Initial Report FDA Received Date: 08/17/2023
• Supplement Report FDA Received Date: 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 62 KG