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

Catalog Number BI70002000-G30

Device Problems Break (1069); Mechanical Problem (1384); Difficult to Open or Close (2921)

Patient Problem No Patient Involvement (2645)

Event Date 12/12/2017

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.A medtronic representative went to the site to test the equipment.It was reported that the door pins were out of alignment.Once realigned, a rotor calibration was performed on the imaging system.The imaging system was then rehomed.The imaging system then passed the system checkout and was found to be fully functional.No parts were replaced, therefore no parts were returned for analysis.

Event Description

A site representative reported that, while outside of a procedure, the gantry door of the imaging system was unable to open.It was reported that when attempting to open the door manually, the x-ray tube and detector could not align.It was reported that they were at the ap position and not moving.High amounts of tension were noted from the tube and detector when attempting to manually open the door.There was no patient present when this issue was identified.No additional information was provided.

Manufacturer Narrative

The hand switch for the imaging system was returned to the manufacturer for analysis.The device was found to be fully functional with no problem found.It was noted that the standoffs on the handswitch were damaged, though this did not affect the functionality of the unit.

Manufacturer Narrative

The damaged part was sent back to the manufacturer for further analysis.Functional, visual and performance testing were conducted.Visual analysis revealed physical damage to the hand switch and confirmed the body standoffs are broken.Physical damage confirmed.

• 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: stephanie riley ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710 ; 7635267745
• MDR Report Key: 7173527
• MDR Text Key: 96720996
• Report Number: 1723170-2018-00104
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 00643169639683
• UDI-Public: 00643169639683
• 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,consum
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Radiologic Technologist
• Device Catalogue Number: BI70002000-G30
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2017
• Initial Date FDA Received: 01/08/2018
• Supplement Dates Manufacturer Received: 01/27/2018; 01/27/2018
• Supplement Dates FDA Received: 02/02/2018; 06/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2016
• 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