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 Break (1069)

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

Event Date 08/20/2018

Event Type  malfunction  

Manufacturer Narrative

A medtronic representative went to the site to test the equipment.Testing revealed that the j4 ribbon connection to the automatic data processing (adp) board was found to be half way pulled out of the connector, and was re-seated properly.The hand switch cord was found to be severely stretched and was replaced.It was also noted that an ethernet coupler was installed onto the back of the mobile viewing station (mvs).The imaging system then passed the system checkout and was found to be fully functional.The hand switch has been returned to the manufacturer and is currently under analysis.

Event Description

Medtronic received information that, while performing a sacroiliac and thoracolumbar procedure, the hand switch cord was stretched out and the x-ray buttons were difficult to press.The o-arm did half a spin and then quit x-ray.The site continued using the hand switch with no issues.There was a reported delay to the procedure of less than 1 hour due to this issue.

Manufacturer Narrative

The hand switch was returned to the manufacturer for analysis.Multiple 2 and 3d images were taken while moving the hand switch around, all were successful.The hand switch failed visual inspection.The cord is overstretched and the two halves of the hand switch are separating.Physically damaged hand switch.Analysis found that the reported event was related to a mechanical issue.If information is provided in the future, a supplemental report will be issued.

• 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: erika mitchellette ; navigation customer quality; 826 coal creek circle; louisville, CO 80027
• MDR Report Key: 7865917
• MDR Text Key: 119931530
• Report Number: 1723170-2018-04544
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 11/16/2018

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: 08/29/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2013
• 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: 69 YR
• Patient Weight: 113