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

Model Number BI-700-00027-120

Device Problems Device Issue (2379); Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/08/2015

Event Type  malfunction  

Event Description

A site representative, radiologic technologist (rt) reported that during a spinal fusion procedure, the imaging system detector positioner cover was damaged.Issue noticed when opening the o-arm door to remove it from around the patient after the post-op 3d spin.A popping noise was heard when opening the door.The surgeon completed the procedure with the use of the imaging system.There was no impact on patient outcome.

Manufacturer Narrative

Patient weight not available from the site.A medtronic representative, following up with the site, tested the system and reported both louver hinges were broken from sterile drapes caught inside the door when 3d spin was acquired.Per imaging system user manual: "caution: carefully watch while the door closes to make sure that no part of the drape is caught inside the door.This could cause internal failure of the components." replacement hinges shipped to site for issue resolution.On (b)(4) 2015, the medtronic representative replaced the hinges and performed an imaging system check-out, all areas passed.The system was reported fully functional after the replacement of the hinges.No parts have been received by the manufacturer for analysis.

• Brand Name: O-ARM 1000 IMAGING SYSTEM
• 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.; 826 coal creek circle; louisville CO 80027 971
• Manufacturer Contact: kristianna bilan ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902338
• MDR Report Key: 4743670
• MDR Text Key: 15899558
• Report Number: 1723170-2015-00542
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050996
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Radiologic Technologist
• Type of Report: Initial
• Report Date: 04/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Radiologic Technologist
• Device Model Number: BI-700-00027-120
• Device Catalogue Number: 9732719
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2012
• 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: 45 YR