MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH ARTIS Q BIPLANE; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number 10848282

Device Problem Use of Device Problem (1670)

Patient Problems Injury (2348); Patient Problem/Medical Problem (2688)

Event Date 12/30/2019

Event Type  Injury  

Manufacturer Narrative

Siemens is conducting a thorough investigation of the reported events.As this event is under investigation, a root cause has not yet been determined.A supplement report will be filed upon completion of the investigation.

Event Description

It was reported to siemens that an adverse event occurred following examination on the artis q biplane system.The user reported that the needle guidance is not accurate.Following a procedure, the patient awoke with numbness, pain, and decreased power in the right lower extremity.Siemens has requested additional information in order to conduct an investigation of the reported event.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.Assessment of the log files does not indicate a system failure or malfunction and no non-conformity was identified.According to the customer the position of the needle guidance graphics of the planned needle path was not as expected when using the needle guidance workflow application.Therefore, an application specialist went on-site in january, 2020 for testing of the needle guidance workflow and 2d/3d overlay accuracy.The system operated as expected with no errors.A final dynact exposure was performed and fused to the original path.The 3d objects were displayed accurately.No issue with the 2d/3d calibration could be identified and the system works as specified.The issue has been simulated in the lab.In the log files of the artis and the xwp system, the needle guidance procedure could be retraced.According to the logs, the table graphics were displayed correctly.The requested stand position for the automatic drive commands are equal to the planned needle paths that can be seen on the 3d snapshot images and the system is moving to this position after adjusting the angles according to the 2d/3d calibration.No errors could be identified for all logged automatic drive commands from the needle guidance application.No system malfunctions, failures or deficiencies could be found or identified with the log files.According to the above a system error can be excluded.Additionally, it is clearly stated in the ifu that the user has to check the course of the needle by means of fluoroscopic images.The system has been checked by the local application specialist and it works as specified.The alleged error did not reoccur.After detailed investigation, the incident is not classified as a reportable event as neither serious injury, death nor an unexpected prolonged hospitalization of the patient or any other person occurred or could be expected.

• Brand Name: ARTIS Q BIPLANE
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemensstrasse 1; forccheim, germany 91301 ; GM 91301
• MDR Report Key: 9601186
• MDR Text Key: 176829314
• Report Number: 3004977335-2020-13756
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• PMA/PMN Number: K181407
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 12/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10848282
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other