MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH ARCADIS ORBIC GEN2; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number 10143407

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/04/2018

Event Type  Injury  

Manufacturer Narrative

Exemption number e2017017.(b)(4).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.(b)(4).

Event Description

Siemens was notified of an adverse event by the (b)(4).The user reported an incorrect intraoperative side view in 3d c-arm.Therefore, an anatomically correct screw on the cervical spine of a patient was positioned twice in the wrong direction.The operation was a high-risk procedure on the 1st and 2nd cervical vertebrae.The labelled page on the screen was reversed.The patients' life was in danger, but fortunately the side shift had no consequences for the patient.The faulty page representation was reproduced on a dummy.The most likely cause was an input error that did not correctly describe the position of the c-arm in the room.In order to avoid similar occurrences, the side of the patient to be operated on is now marked with a small metal marker which is shown in the x-ray image.Siemens has requested additional information regarding the reported event in order to conduct a complete investigation.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.No system failure or non-conformity was identified the investigation showed that there was no system failure.The operating instructions explicitly state that the operator should use lead letters to avoid side mistakes.After contacting the customer, it was confirmed that the operator did not work according to the instructions.The manufacturer is not considering further actions resulting from this event as no systematic error has been recognized.

• Brand Name: ARCADIS ORBIC GEN2
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forccheim, germany 91301 ; GM 91301
• MDR Report Key: 8263802
• MDR Text Key: 133719060
• Report Number: 3004977335-2019-63949
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• PMA/PMN Number: K042793
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 01/08/2019

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
• Device Operator: Health Professional
• Device Model Number: 10143407
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/27/2019
• Event Location: Hospital
• Date Report to Manufacturer: 01/08/2019
• Initial Date Manufacturer Received: 01/08/2019
• Initial Date FDA Received: 01/21/2019
• Supplement Dates Manufacturer Received: 02/27/2019
• Supplement Dates FDA Received: 02/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other