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

Catalog Number BI70002000

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/26/2018

Event Type  malfunction  

Manufacturer Narrative

A medtronic representative went to site to test the equipment.Representative reported that rebooting the issue resolved the issue.Upon inspection, the umbilical cable had a piece of plastic cover covering a pin thus causing the intermittent issues with stand alone mode.The plastic was removed and the issue resolved.The umbilical cable was reseated several time and the the system was working as designed.Site had no issues with spins.A system checkout was performed and the hardware, software, and instruments passed the system checkout.The system was found to be fully functional.No parts have been replaced.No parts have been received by the manufacturer for evaluation.

Event Description

A site representative reported that during functional endoscopic sinus surgery (fess), the imaging system booted into stand alone mode.Rebooting the system with mobile view station (mvs) and image acquisition system (ias) disconnected did not resolve the issue.The issue resolved after the umbilical cable was re-seated and the system booted into 2d mode.The procedure was completed with the use of imaging.There was a delay of 20 minutes.No impact on patient outcome.

• 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: prashanth gali ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902515
• MDR Report Key: 7286171
• MDR Text Key: 100672850
• Report Number: 1723170-2018-00802
• 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: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Radiologic Technologist
• Device Catalogue Number: BI70002000
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2016
• 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: 46 YR
• Patient Weight: 78