MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LITTLETON) O-ARM 1000 IMAGING SYSTEM 3RD EDITION; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE

Model Number BI-700-00028-120

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 05/16/2018

Event Type  malfunction  

Manufacturer Narrative

Onsite functional and visual examination was performed by a manufacturer representative.The representative replaced the door cable and the issue was resolved.The system passed a system checkout and was found to be fully operational.

Event Description

Medtronic received information regarding an imaging device being used outside of procedure.It was reported that the cable controlling the gantry door broke when they were trying to open the door.

• Brand Name: O-ARM 1000 IMAGING SYSTEM 3RD EDITION
• 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: parker desautel ; navigation customer quality; 826 coal creek circle; louisville, CO 80027
• MDR Report Key: 7586980
• MDR Text Key: 110619904
• Report Number: 1723170-2018-02644
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• Reporter Country Code: ES
• PMA/PMN Number: K092564
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 06/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: BI-700-00028-120
• Device Catalogue Number: BI70000028120
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2014
• 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