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

Catalog Number BI70002000

Device Problems Break (1069); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/07/2017

Event Type  malfunction  

Manufacturer Narrative

Patient information was unavailable from the site.A medtronic representative went to site to test the equipment.Representative reported that a front rotor fan fin was damaged and made a loud popping noise.The fan assembly was replaced to resolve the issue and a system checkout was performed.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional.The suspect part has not been receive by the manufacturer for evaluation.

Event Description

A site representative reported that during spinal fusion procedure, a loud popping noise was heard from imaging system and a black plastic was falling from the system when closing the gantry around a patient.When opening the gantry, no noise was heard from the system and system was removed from the operating room (or).The procedure was completed without the use of imaging.There was a delay of less than 1 hour.No impact on patient outcome.

Manufacturer Narrative

Additional information: patient id, age and gender provided.A medtronic representative reported that the issue occurred in a lumbar laminectomy with a pedicle screw fusion.

Manufacturer Narrative

Patient demographic information.Patient weight not available from the site.

Manufacturer Narrative

The fan assembly for the imaging system was returned to the manufacturer for evaluation.Testing found that a fan blade was damaged and resulted in the reported issue.

Manufacturer Narrative

Correction: a medtronic field service engineer clarified that the fan blade broke inside the system, and did not fall off until after the fan cover was removed while servicing the system.Additional information/response to fda request: attached with this submission is a copy of the response letter sent to the fda on (b)(4) 2018 with regards to a fda request for additional information ((b)(4)) that provides additional information and findings related to this mdr.

Manufacturer Narrative

• 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: amos jarrette ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710 ; 7208903200
• MDR Report Key: 7083886
• MDR Text Key: 93818086
• Report Number: 1723170-2017-04958
• 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,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/07/2018

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/07/2017
• Initial Date FDA Received: 12/05/2017
• Supplement Dates Manufacturer Received: 12/11/2017; 02/16/2018; 02/16/2018; 04/30/2018; 09/06/2018
• Supplement Dates FDA Received: 01/08/2018; 03/06/2018; 03/08/2018; 05/29/2018; 09/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2017
• 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: 72 YR