MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LITTLETON) O-ARM O2 IMAGING SYSTEM; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Catalog Number BI70002000

Device Problems Imprecision (1307); Image Reversal (1358); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/16/2016

Event Type  malfunction  

Manufacturer Narrative

Patient identifier has not been provided by the site.A medtronic representative performed troubleshooting on the imaging system on-site.The following was done to resolve the issue: on (b)(4) 2016 - a separate issue was reported for an error on this imaging system.On (b)(4) 2016 - the detector panel was replaced by the medtronic representative in an attempt to resolve the issue reported on (b)(6) 2016.On (b)(4) 2016 - the medtronic representative discovered that the new detector panel had been installed in the incorrect orientation on (b)(4) 2016.This was confirmed to have directly caused the reported reversed image orientation.The panel was reinstalled correctly, and the issue resolved.A full imaging system check-out was completed following re-installation of the detector panel, and all tests passed.Full system functionality was confirmed and the system was returned to service.

Event Description

A medtronic representative reported that during a spinal fusion procedure, the imaging system was displaying anteroposterior (ap) and lateral images in the reverse orientation as intended.When the imaging system was being lined up for a 3d spin for navigation, an inaccuracy was noted because of this issue.The use of this imaging system was discontinued, and the procedure was completed successfully with a second medtronic imaging system after a 15 minute delay.The patient was not impacted by this event.No additional details were provided.

• Brand Name: O-ARM O2 IMAGING SYSTEM
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LITTLETON); 300 foster street; littleton MA 01460
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC. (LITTLETON); 300 foster street; littleton MA 01460
• Manufacturer Contact: nicholas mcnabb ; 826 coal creek circle; louisville, CO 80027 ; 7208902439
• MDR Report Key: 5652965
• MDR Text Key: 45125484
• Report Number: 1723170-2016-00788
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 05/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Radiologic Technologist
• Device Catalogue Number: BI70002000
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 88