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

Catalog Number BI70000028230

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 03/28/2018

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.A manufacturer representative went to the site to test the imaging system.It was reported that the following were replaced: 2 lower lexan channels; 135 degree inner gantry cover; detector louver position cover.A full system checkout was performed after part replacement and all tests passed.The replaced parts were not returned to the manufacturer for evaluation, as the parts were discarded by the site.The cause of the issue remains unknown, but replacing parts, the system works as intended.

Event Description

Medtronic received information regarding an imaging device being used outside of procedure, with no patient present.It was reported that during a software upgrade, the following were observed: broken cover inner gantry; lexan channels; and cover source position louver.

Manufacturer Narrative

A manufacturer representative went to the site to test the imaging system.It was reported that the following were replaced: 2 lower lexan channels; 135 degree inner gantry cover; detector louver position cover.A full system checkout was performed after part replacement and all tests passed.The replaced parts were not returned to the manufacturer for evaluation, as the parts were discarded by the site.System fully functional.

• 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: stephanie riley ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710 ; 7635267745
• MDR Report Key: 7654861
• MDR Text Key: 112885361
• Report Number: 1723170-2018-03070
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• PMA/PMN Number: K092564
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: BI70000028230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2014
• 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