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

Model Number	10762473
Medical Device Problem Code	Unintended Collision (1429)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2025
Type of Reportable Event	Malfunction
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 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 upon completion of the investigation.
Event or Problem Description
Siemens healthineers became aware of an issue associated with the uroskop omnia max system.The system was driven into an operating room light arm elbow.No mention of falling parts due to the collision or resulting injury was made to siemens healthineers.In a worst-case scenario, serious injury could result from a collision of the system with external objects if parts were to fall down and hit a person.
Additional Manufacturer Narrative
H3, h6: siemens healthineers completed a detailed investigation of the reported problem.It was reported that the system collided with an operating room light arm elbow when it was moved up.Additional information revealed that the collision caused damage to the tube housing cover and misalignment of the tube.This misaligned tube resulted in a cutoff on the top of the image.The investigation showed that the issue occurred because the operator did not check the system collision zone before initiating the system movement, as described in the operator manual (xpl5-360.620.01.01.02, register 1: safety, chapter: collision hazard - risk of collision during unit movements, p.24).In general, system movements may only be performed if they do not endanger anyone or any equipment.The system was repaired by siemens local service organization with realignment of the tube.According to the information available the damaged cover has not been replaced yet.However, this damaged cover is only cosmetic and is not related to the safety of the system.The staff was informed that the operating room light arm may not be placed over the system before starting movements.No system failure could be identified.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: 23632370
• Report Number: 3004977335-2025-00136
• Device Sequence Number: 21427673
• Product Code: OWB
• UDI-Device Identifier: 04056869008981
• UDI-Public: (01)04056869008981
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2026

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: 10/30/2025
• Supplement Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 01/30/2026
• 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