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

Catalog Number BI70002000

Device Problems Bent (1059); Break (1069); Mechanical Problem (1384); Device Operates Differently Than Expected (2913); Positioning Problem (3009)

Patient Problem No Patient Involvement (2645)

Event Date 12/11/2017

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.Device lot number, or serial number, unavailable.A manufacturer representative was able to go on-site to evaluate the device.Visual and functional testing was able to confirm the physical damage to the x-stage cover.The cover was replaced and system checkout was successful.The damaged cover was returned to the manufacturer for analysis.Visual and functional examination the cover failed visual inspection and found dents and chipping paint around the docking hole.This confirmed the physical damage.

Event Description

Medtronic received information regarding an imaging device.It was reported that the device was not able to dock.Additionally, the site noted that the x-stage cover was damaged.This was observed outside of a surgical procedure.No patient involved.

• 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: stephanie riley ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710 ; 7635267745
• MDR Report Key: 7664181
• MDR Text Key: 113241804
• Report Number: 1723170-2018-02782
• Device Sequence Number: 1
• Product Code: OWB
• 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,consum
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 07/05/2018

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: 01/02/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/11/2017
• Initial Date FDA Received: 07/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/20/2016
• 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