MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LITTLETON) O-ARM 1000 IMAGING SYSTEM; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE

Model Number BI-700-00027-120

Device Problems Mechanical Problem (1384); Device Operates Differently Than Expected (2913)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 01/23/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information was unavailable from the site.A medtronic representative went to the site to test the equipment.The representative reported that a surgeon at the site had driven the imaging system into a x-ray viewer box.It was reported that after manual adjustment of the door locks restored functionality to the imaging system.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 medtronic representative reported that, while in a procedure, the gantry door of the imaging system was unable to close entirely.It was reported that the imaging system was restarted 3 times, along with manual adjustment of the interface (umbilical) cable, restored functionality.It was reported that the pendant displayed that the door was open when the gantry door was closed.It was noted that a "clicking" noise emitted from the imaging system.There was no known impact on patient outcome.No additional information was provided.

Manufacturer Narrative

Additional information: the reported issue occurred in a lumbar posterior spinal fusion.It was noted that there was a 90 degree kink in the interface (umbilical) cable that did not allow the imaging system to operate.A second medtronic imaging system was brought into the operating room (or) to complete the procedure.There was a reported delay to the procedure of around half an hour due to this issue.Patient demographics provided.

• Brand Name: O-ARM 1000 IMAGING SYSTEM
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE
• 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: peter verhey ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710
• MDR Report Key: 7266726
• MDR Text Key: 100046306
• Report Number: 1723170-2018-00666
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050996
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 03/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Radiologic Technologist
• Device Model Number: BI-700-00027-120
• Device Catalogue Number: 9732719
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2014
• 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