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 Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 08/10/2017

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.The x-stage cover was returned to the manufacturer for analysis.Analysis found that it had multiple scratches and dents around the docking pin holes.Analysis found that the reported event was related to a mechanical issue.A medtronic representative went to the site to test the equipment.Testing revealed that the x-stage covers were damaged, so it was replaced.The imaging system then passed the system checkout and was found to be fully functional.

Event Description

Medtronic received information regarding an imaging system being used outside of a procedure.It was reported that while troubleshooting, it was discovered that the x-stage cover was damaged.There was no patient present.

• 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: stephanie riley ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710 ; 7635267745
• MDR Report Key: 7584431
• MDR Text Key: 110577057
• Report Number: 1723170-2018-02323
• 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
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 06/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2018
• 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: 08/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2009
• 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