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); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: the reporting facility contact name was not provided for reporting.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: the root cause of the collison is under investigation.No system malfunction has been determined at this time.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.
Event or Problem Description
Siemens healthineers became aware of an event associated with the uroskop omnia max system.During an intervention the system was driven into the swivel arm of an external object mounted to the ceiling, presumably an operating room light.The tube assembly mount was bent due to the collision.No falling parts were mentioned.No injury to the patient or staff were communicated.In a worst-case scenario, serious injury could result from falling parts due to a collision of the system with external objects.
Additional Manufacturer Narrative
H3, h6: siemens healthineers completed a detailed investigation of the reported problem.The investigation showed that the system was driven by the operator into an external ceiling-mounted swivel arm of a surgical lamp which extended into the operating range.This resulted in a collision and severe damage to the system.The system was successfully repaired at customer site by factory technicians.The customer was advised to ensure that no external objects are in the system¿s operating range when moving the system.This is also described in the system user manual under "safety".The investigation did not indicate any system malfunction, the system worked as specified.External movable objects, such as a surgical lamp, could not be included in the collision calculation of the system.The complaint was 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: 23509865
• Report Number: 3004977335-2025-00130
• Device Sequence Number: 21265662
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2025

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: 11/06/2025
• Supplement Date Received by Manufacturer: 12/23/2025
• Initial Report FDA Received Date: 11/10/2025
• Supplement Report FDA Received Date: 12/23/2025
• 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
• Patient Sex: Unknown