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 Problems Image Resolution Poor (1306); Poor Quality Image (1408); Device Issue (2379)

Patient Problems Spinal Column Injury (2081); Iatrogenic Source (2498)

Event Date 03/06/2015

Event Type  Injury  

Event Description

A medtronic representative reported that during a spinal fusion procedure, the surgeon had to re-position a screw.The site reported the imaging system was behaving unexpectedly.It was reported the imaging system was not opening causing the system to remain stationary over the patient.It was also reported the imaging system would not change from 2d imaging to 3d imaging and the imaging system would not power down.To troubleshoot these issues the site manually opened the door halfway, the system was then able to close as expected.The site then took fluoro shots and when performing a 3d spin, the imaging system made a loud noise.The resulting image quality of the screw from this spin was poor and surgeon was unable to confirm the placement.The surgeon opted to complete the procedure without the use of the imaging system and decided to replace the screw under fluoro to confirm placement.

Manufacturer Narrative

A review of the logs found the o-arm took a successful 2d scan.The logs then showed an error message which indicated the digital motion controller message was invalid.However, the command was valid and has been used in the past.The logs then showed the following warning message: "motion control status not active." with the motion control component inactive, the o-arm went into standalone mode.The logs also showed that the user repeatedly pressed the lift and shift button.Each lift and shift request was followed by a timeout error from the digital motion controller.This was consistent with the operator complaint that the lift and shift mechanism was not functional.The logs showed that the positioner motion controller disconnected and the gantry motion controller disconnected.After examining the source code it was determined that the oncontrollererroroccurredevent function disconnected the motion controllers, positioner and gantry, when a communication error was encountered.The logs showed a stream of "invalid controller handle" error messages.These messages indicated that the software was still trying to communicate with the motion controllers.Tthe software then reestablished communications with the motion controllers and the o-arm returned back to 2d mode.This transition occurred despite an "all motion controllers not homed" warning.The logs showed the user repeatedly pressed the lift and shift button.The user was then able to switch to 3d mode as indicated by the following message: "acquisition mode changed from 2d to 3d." this fact contradicted the user claim that the o-arm would not switch modes.The user switched back to 2d mode, the user continued to press the applicationmode2d button several more times.The o-arm then stopped writing messages to the logs.The software investigation found that the reported event was related to a software issue.This issue was documented in a medtronic navigation software anomaly tracking database.On (b)(4) 2015, a medtronic representative performed an imaging system check-out, all areas passed.

Manufacturer Narrative

Per further engineering review, there was no re-occurrence of this issue since it was initially reported on this system and a review of the complaint history found no similar hardware issues reported.The safety risk management (srm) assessment for the reported incident was found to be ¿negligible¿.

Manufacturer Narrative

On (b)(4) 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 (b)(4) 2015 to (b)(4) 2016.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-2016.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.

• 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.; 826 coal creek circle; louisville CO 80027 9710
• Manufacturer Contact: kristianna bilan ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902338
• MDR Report Key: 4653020
• MDR Text Key: 5729655
• Report Number: 1723170-2015-00396
• Device Sequence Number: 1
• Product Code: OXO
• 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: User Facility,Company Representative,company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date: 07/08/2015,02/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Radiologic Technologist
• Device Model Number: BI-700-00028-120
• Device Catalogue Number: BI70000028120
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 07/08/2015
• Distributor Facility Aware Date: 06/09/2015
• Date Manufacturer Received: 01/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2014
• 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): Required Intervention