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 Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913); Issue With Displayed Error Message (2967)

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

Event Date 02/10/2015

Event Type  malfunction  

Event Description

A medtronic representative reported that, upon boot-up of the imaging system, the site received the message: collimator initialization error.The surgeon opted to discontinue the use of the imaging system to go forward and completed the procedure.There was no impact on patient outcome reported.

Manufacturer Narrative

Patient information was not made available from the site.(b)(4) 2015 - a medtronic representative performed an imaging system check-out, failed mechanical test.Results indicated a mechanical jam in the collimator.After inspection no mechanical jam was present in the collimator.After replacement of the collimator the problem still persisted.Trouble-shooting did not resolve the issue.It was decided to replace the collimator and re-test.After the replacement of the collimator the problem was still present and it was determined the rotor motor controller should be replaced.(b)(4) 2015 - a medtronic representative performed an imaging system check-out, failed mechanical test.The original issue, error initializing collimator, persisted.Rotor motor controller replaced.System functions checked ok.(b)(4) 2015 - a medtronic representative performed follow-up imaging system check-out, failed mechanical test.Pendant of o-arm showed the following message: error initializing collimator.In trouble-shooting: opened dmc smart terminal and attempted re-homing the collimator; un-jammed the coly motor, checked ok.System functions checked ok.(b)(4) 2015 - medtronic representative un-tightened the retaining screws for the collimator plates.(b)(4) 2015 - a medtronic representative, following-up at the site, reported that the system failed when the o-arm was due to scan the head for a deep brain stimulation (dbs) case.The patient was then sent to computed tomography (ct) while under anaesthetic and would have returned to confirm placement of the leads, this would have been over an hour.

Manufacturer Narrative

Patient information provided.Patient weight was unavailable.A medtronic representative clarified that the terminal was opened to re-home the collimator.The terminal showed that the stroke error for collimator was above 1.25 inches.The rep was able to physically/mechanically unlock the collimator motor.This resolved the issue and no parts were used or will be returned for this specific event.A cross functional engineering review found that the reported error prevents initialization of the o-arm imaging system, rendering the system unusable until the error is rectified.When this error is displayed on the pendant, the error message also states "stand alone mode." per the o-arm imaging system user manual, stand alone mode occurs when "the [image acquisition system] (ias) is disconnected from the [mobile view station] (mvs).In this mode, the ias receives its power from 40 lead-acid storage batteries to perform all positioning and movement functions.The x-ray generator is deactivated in the standalone mode, so it is not possible to take images." as use is prevented via this system mitigation, no additional mitigation is included in instructions for use.

• 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: amos jarrette ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902082
• MDR Report Key: 4587023
• MDR Text Key: 5338545
• Report Number: 1723170-2015-00282
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K050996
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 02/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2015
• 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?: No
• Date Manufacturer Received: 03/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2012
• 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: 59 YR