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 Failure to Fire (2610)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/05/2018

Event Type  malfunction  

Manufacturer Narrative

A medtronic representative went to the site to test the equipment.Testing revealed that this event could not be duplicated, but errors in the log files indicating a possible faulty hand switch were found.The hand switch was replaced and the system was returned to service.The imaging system then passed the system checkout and was found to be fully functional.The hand switch was returned to the manufacturer for analysis.Analysis found that the hand switch functioned as expected.It performed 2d and 3d imaging, as well as store features, successfully.However, the hand switch failed visual inspection.The cord was over stretched.Analysis found that the reported event was related to a electrical issue.

Event Description

Medtronic received information regarding a navigation device being used during a posterior spinal fusion procedure.It was reported that the imaging system took about 1/10th of the 3d spin and stopped.The spine representative restarted the system, took another spin, and it worked.There was a surgical delay of less than 1 hour due to this issue, and there was no impact on patient outcome.

• 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: maxwell roth ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710
• MDR Report Key: 7865841
• MDR Text Key: 119933322
• Report Number: 1723170-2018-04353
• Device Sequence Number: 1
• Product Code: OXO
• UDI-Device Identifier: 00643169353428
• UDI-Public: 00643169353428
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092564
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BI-700-00028-120
• Device Catalogue Number: BI70000028120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2015
• 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: 74 YR
• Patient Weight: 104