MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH 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	06/20/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The user drove the urokop omnia max system upwards where it collided into a surgical light.No falling parts were mentioned.No patient involvement or injury was communicated for this event.In worst case scenario, persons could be seriously injured by falling parts due to a collision of the system with external objects.The issue is reported with an abundance of caution.The reported event occurred in germany.
Additional Manufacturer Narrative
A facility contact name and telephone number were not provided to siemens.Manufacturers preliminary analysis: with the currently available information no system malfunction has been found.Currently it is not clear what the reason for the collision was.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.Suspended accessories should not be installed in the collision range of the system.The investigation is ongoing.Initial corrective actions/preventive actions implemented by the manufacturer: no general problem has been detected for the installed base which requires an immediate action.A supplemental report will be submitted if additional information becomes available.Internal id# (b)(4).
Additional Manufacturer Narrative
The reported issue was investigated in detail.The damage was evaluated by the basic unit experts.The investigation of the provided pictures showed the room constellation with the surgical light mounted directly about the system.Furthermore, the damage to tower tube case unit and the rail which guides the tube longitudinal movement was seen.According to the information received by the service organization the surgical light was installed by the customer after the uroskop omnia max was installed.To avoid such a collision the customer should have called the siemens service organization to check if the surgical light can be placed in this position or at least to adapt the room configuration of the uroskop omnia max collision calculation.In operator manual xpl5-360.620.01.01.02 (chapter "safety" on pages 49/ 54 and 50/ 54) a detailed description of how to avoid mechanical damage to the system can be found.The system was repaired on site by the service organization supported by system experts and is back in working condition.Since no system malfunction could be identified the complaint is closed without further measures.Internal id# (b)(4).

• Brand Name: UROSKOP OMNIA MAX
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 14946271
• Report Number: 3004977335-2022-33356
• Device Sequence Number: 12010748
• Product Code: OWB
• UDI-Device Identifier: 04056869008981
• UDI-Public: 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2022

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: 10762473
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2022
• Supplement Date Received by Manufacturer: 08/18/2022
• Initial Report FDA Received Date: 07/07/2022
• Supplement Report FDA Received Date: 08/18/2022
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown