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); Unintended Movement (3026)

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

Event Date 03/11/2015

Event Type  malfunction  

Event Description

A medtronic representative reported that during a spinal fusion procedure the imaging system was driving back toward the user as soon as the handle was squeezed, even though the user wasn't pushing or pulling on the system.The medtronic representative also reported the imaging system was accelerating too quickly.The surgeon opted to cancel and reschedule the procedure, but not due to this issue, due to a different issue documented in mfr report number 1723170-2015-00431.

Manufacturer Narrative

Surgeon aborted the procedure for separate issue reported in 1723170-2015-00431, there was no known impact or consequence to patient or user due to this reported issue.On (b)(4) 2015, a medtronic representative tested the system and was able to replicate the issue, although not every time.Replacement devices shipped to site for issue resolution.The medtronic representative replaced the motion control pcb board and strain gauges.The medtronic representative then calibrated the new motion control pcb and 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

Suspect motion control board was analyzed: the issue was duplicated.An electrical failure caused the event.Confirmed reported problem "o-arm is driving in reverse and it happened multiple times, but not every time".When motion control pcb was installed in a test o-arm system, the test o-arm was driving in reverse and motion was jumpy at times.Motion is unstable and intermittent.Defective motion control pcb caused event.Strength guage was also returned but found to be fully functional.

Manufacturer Narrative

Correction: it was discovered on 27-jan-2016, that an incorrect date was referenced in a previous supplemental 3500a submission.The reported date of 16-aug-2016 was reported incorrectly and should be 16-aug-2015.Statement in previous supplemental 3500a submission should read: ¿on 30-jun-2015, it was noticed that a coding error in mdr submissions from our facility resulted in the maude database incorrectly coding the devices related to our mdr submissions from 25-may-2015 to 16-aug-2015.The decision to wait until the database was corrected was made after consultation with the fda as advised by a consumer safety officer with the information analysis branch, division of post market surveillance, office of surveillance and biometrics.An it solution was implemented on 16-aug-2015.This mdr was submitted to correct the coding error.There is no new information to change the patient information, event description and/or manufacturer narrative that was previously reported.¿.

Manufacturer Narrative

As previously reported the motion control board was confirmed to have caused the imaging system to drive in reverse.The motion control board was sent to the supplier for investigation but supplier testing was unable to find a fault on the board.A search for similar incidences of this failure on the board was conducted, but no related complaints were found.No recurrences of the failure has been reported since the replacement of the board and the strain gauge.

• 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: 4665420
• MDR Text Key: 5619079
• Report Number: 1723170-2015-00432
• 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,Followup,Followup
• Report Date: 06/19/2015,03/16/2016

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?: 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 06/19/2015
• Distributor Facility Aware Date: 05/20/2015
• Date Manufacturer Received: 02/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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 Age: 50 YR
• Patient Weight: 136