MAUDE Adverse Event Report: VERAN MEDICAL TECHNOLOGIES, INC. SYS-3000 - IG4 SYSTEM, 120V, 6OHZ; COMPUTED TOMOGRAPHY X-RAY SYSTEM

Model Number	SYS-3000
Medical Device Problem Code	Failure to Sense (1559)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A company representative, on behalf of a customer, reported that the physician felt the "registration" of the veran spin sys-3000 did not function well and was not accurate during a biopsy procedure, despite following veran protocol.The navigation portion of the procedure could not be performed, and was aborted, incurring a 1 hour delay while the patient was under anesthesia (midazolam).The physician was able to complete the procedure with fluoroscopy guided transbronchial lung biopsy that same day, which was the facilities standard back up plan.The patient outcome was not provided.
Additional Manufacturer Narrative
The device was not returned for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide corrected information based on the review of the complaint.
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: SYS-3000 - IG4 SYSTEM, 120V, 6OHZ
• 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: 18137023
• Report Number: 3007222345-2023-00155
• Device Sequence Number: 12374301
• Product Code: JAK
• UDI-Device Identifier: 00815686020088
• UDI-Public: 00815686020088
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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,Company Representative
• Initial Reporter Occupation: Physician
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SYS-3000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2023
• Supplement Date Received by Manufacturer: 11/15/2023; 03/15/2024
• Initial Report FDA Received Date: 11/14/2023
• Supplement Report FDA Received Date: 11/29/2023; 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 40 KG