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 Problems Tissue Damage (2104); Iatrogenic Source (2498)

Event Date 03/11/2015

Event Type  Injury  

Event Description

A medtronic representative reported that during a spinal fusion procedure the imaging system was displaying the door as open even though the door was completely closed.The patient was under anesthesia and the surgeon had already decompressed the spine when this issue occurred.The surgeon opted to cancel the procedure and reschedule for a later date.

Manufacturer Narrative

A medtronic representative, following up with the site, reported that once the imaging system was fixed the surgery was completed.The medtronic representative reported the rescheduled case went well with no issues reported.On (b)(4) 2015, a medtronic representative tested the system and found the imaging system door was locked up.The medtronic representative re-calibrated the system by re-homing the motion controls.The medtronic representative then performed a imaging system check-out and reported all areas passed.Issue was resolved on site.No parts have been received by the manufacturer for analysis.

Manufacturer Narrative

Further investigation into this event by a quality engineer found: there is insufficient information to conclude the cause of the imaging system door not closing.As the issue was resolved by re-homing the motion systems, it is suspected that the event may have been due to a rotor alignment issue or a homing issue, however this cannot be confirmed at this time.No further issues reported.

• 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. (LITTLETON); 300 foster street; littleton MA 01460
• Manufacturer Contact: kristianna bilan ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902338
• MDR Report Key: 4665128
• MDR Text Key: 16076401
• Report Number: 1723170-2015-00431
• 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: User Facility,Company Representative,company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 05/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2015
• Is this an Adverse Event Report?: Yes
• 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?: No
• Date Manufacturer Received: 05/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2008
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 50 YR
• Patient Weight: 136