MAUDE Adverse Event Report: SIEMENS HEALTHINEERS AG SOMATOM X.CEED; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number	11330002
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	10/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Siemens is conducting a thorough investigation of the reported event.As this event is under investigation, a root cause has not yet been determined.A supplement report will be filed if additional information becomes available.
Event or Problem Description
It was reported to siemens that an adverse event occurred while operating the somatom x.Ceed ct system.Varian reported that a physician was using the siemens healthineers myneedle laser to plan and place the varian ib mw (intelliblate microwave) needles.Following the placement, imaging revealed that the needles were not positioned as intended, resulting in a partial pneumothorax of the patient¿s right lung.To address the complication, the physician inserted a 10f chest drain, and the procedure continued without further adverse health effects for the patient.
Additional Manufacturer Narrative
Siemens healthineers has completed a comprehensive investigation of the incident.The provided logs and calibration reports were reviewed; however, the actual root cause could not be determined.The available extensive savelog did not extend to the date of the incident.Analysis of automatically collected log files indicates that the integrated laser guide (ilg) lasers 2 and 3 were used to visualize the needle path at the reported time of the incident.There is no evidence of any system malfunction.The supplied laser calibration reports confirm that the laser system was functioning correctly.No further investigation was possible with the information available.No general product or design issue was identified.

• Brand Name: SOMATOM X.CEED
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHINEERS AG; siemensstrasse 1 or; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHINEERS AG; siemensstrasse 1 or; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer Contact: marion mints ; 40 liberty blvd; malvern, PA 19355 ; 4843231632
• MDR Report Key: 23465951
• Report Number: 3004977335-2025-00127
• Device Sequence Number: 10122345
• Product Code: JAK
• UDI-Device Identifier: 04056869231051
• UDI-Public: (01)04056869231051
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K233650
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2025

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: 11330002
• 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: 11/03/2025
• Supplement Date Received by Manufacturer: 12/10/2025
• Initial Report FDA Received Date: 11/04/2025
• Supplement Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown