MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH UROSKOP OMNIA MAX; IMAGE-INTENSIFIED 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	12/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reason for collision is presently unknown.It is user's responsibility to ensure that no objects are in the collision range of the tube assembly.Investigation is ongoing.A supplemental report will be submitted if additional information becomes available.Internal id# (b)(4).
Event or Problem Description
Siemens was informed about an incident that occurred with the uroskop omnia max device.The user drove the tube assembly into a surgical light.This collision resulted in a dent in the tube cover and a crack in the top cover.No falling parts were reported to siemens.The x-ray field remained centered.There are no injuries attributed to this event.
Additional Manufacturer Narrative
The issue was investigated in detail.According to the provided information, the system was raised until the tube collided with a surgical light, which had been installed at the customer site prior to the uroskop system.The investigation of the provided pictures showed that the ceiling mounted light is outside the movement area of the system.However, it is possible to move the swiveling arm in and out of the movement area.On the pictures it can also be seen that the joint of the arm fits to the point of collision.Another provided picture showed a dent on the tube at the point of collision.The provided data was also evaluated by experts from the manufacturer for additional risks and damages, but no critical damage could be identified.It is strongly recommended to check the concerned unit that there is no decentering between the xray tube and the detector and to ensure there are no unusual noises or vibrations during system movements.Otherwise, the service organization must be informed immediately.Furthermore, if there is any oil leakage or potential malfunction of the tube, it is recommended to replace the tube.In the operator manual "xpl5-360.620.01.01.02", chapter "1 safety" on page 20 / 54 it is described that the operator must ensure that no movable parts are in the area of system movement since collisions can occur with other room equipment and mobile objects such as in this case.Since no general problem or further hazard was identified the complaint is closed without further measures.

• Brand Name: UROSKOP OMNIA MAX
• Common Device Name: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• MDR Report Key: 11059654
• Report Number: 3004977335-2020-60342
• Device Sequence Number: 16790820
• Product Code: OWB
• UDI-Device Identifier: 04056869008981
• UDI-Public: 04056869008981
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2020

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
• Initial Date Received by Manufacturer: 12/16/2020
• Supplement Date Received by Manufacturer: 02/05/2021
• Initial Report FDA Received Date: 12/22/2020
• Supplement Report FDA Received Date: 02/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other