MAUDE Adverse Event Report: SIEMENS HEALTHINEERS AG UROSKOP OMNIA MAX; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number	10762473
Medical Device Problem Codes	Unintended Collision (1429); Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Siemens healthineers became aware of an issue associated with the uroskop omnia max system.The system was driven into an x-ray shield by the customer.The tube cover was damaged during the collision.No falling parts were mentioned by the customer.The customer demounted the x-ray shield to minimize the collision risk.Although no injury occurred due to this event, in a worst-case scenario, persons could have been seriously injured by falling parts due to a collision of the system with external objects.
Additional Manufacturer Narrative
H3, h6: initial actions (corrective and/or preventive): no general problem has been detected for the installed base which requires immediate action.Manufacturer's preliminary results and conclusion: no system malfunction could be determined.It is in the responsibility of the user to take care that no objects are in the collision range of the system.There is a corresponding note in the operator manual.A supplemental report will be submitted to the fda if additional information is obtained upon completion of the investigation.
Additional Manufacturer Narrative
H3, h6: siemens healthineers completed a detailed investigation of the reported problem.The investigation showed that the fixed base of the x-ray shield on the ceiling was installed outside of the movement path of the basic unit.However, the collision happened with the moveable arm from the x-ray shield which was positioned within the movement path of the system.The position of this moveable arm is not monitored by the uroskop omnia max collision calculation.Therefore, the operator has to pay special attention to the travel range of these parts.This is also described in the operator manual.It was suggested to the customer to replace the tube assembly as precaution.According to the information received this was refused by the customer.Since no system malfunction could be determined, the complaint has been closed.

• Brand Name: UROSKOP OMNIA MAX
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• 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: rebecca tudor ; 40 liberty blvd.; malvern, PA 19355 ; 4843234198
• MDR Report Key: 23803958
• Report Number: 3004977335-2025-00145
• Device Sequence Number: 21149847
• Product Code: OWB
• UDI-Device Identifier: 04056869008981
• UDI-Public: (01)04056869008981
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K173639
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2026

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: 10762473
• 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: 11/27/2025
• Supplement Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 03/12/2026
• 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
• Patient Sex: Unknown