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); Device Operates Differently Than Expected (2913)

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

Event Date 03/26/2015

Event Type  Injury  

Event Description

A medtronic representative reported that, at the beginning of a spinal fusion procedure, the imaging system shook and stopped functioning.It was reported some of the o.R.Staff noted that they heard something fall inside the imaging system.The medtronic representative reported the imaging system would not open.The surgeon opted to cancel and reschedule the procedure.

Manufacturer Narrative

A medtronic representative, checked the system and reported part of a sterile drape was trapped during a closure of the imaging system, causing the system to become jammed.Replacement covers, tray, hinges and springs shipped to site for resolution.On (b)(6) 2015, a medtronic representative replaced the damaged components and removed sterile drape inside of gantry.The medtronic representative then performed an imaging system check-out, all areas passed.Medtronic investigation of returned suspect gantry cable tray finds that the tray is bent, twisted and sheet metal slightly torn.Physical damage - dented, nicked, scratched, bent medtronic investigation of returned suspect louver cover finds that the louver is bent.The louver has encountered force or pressure to cause it to bend.Physical damage - dented, nicked, scratched, bent medtronic investigation of returned suspect hinges finds that the hinges are both broken at the threaded wells.Mechanical - fracture medtronic investigation of returned suspect springs finds that one spring exhibits severe stretching, the other spring exhibits stretching at the hook.Mechanical - overstretching the reported event was confirmed to be caused by sterile drape stuck in the imaging system.

Manufacturer Narrative

Per further engineering review, a capa was created to address the reported incident.The root cause was found to be insufficient user caution in assuring that the drapes were not caught in the gantry door.The instructions for use (ifu) that accompanies the device cautions to make sure that no part of the drape gets caught inside the door because it can cause internal failure of components.Field data was analyzed and an additional root cause was that the door components were not designed to withstand the force that can be introduced by a user, during different scenarios, regarding drapes being accidentally caught inside the gantry door.A risk assessment was completed and the assessment calculated residual risks that indicated a low risk.

• 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 9710
• Manufacturer Contact: amos jarrette ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902082
• MDR Report Key: 4725237
• MDR Text Key: 5750172
• Report Number: 1723170-2015-00502
• 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: 10/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2015
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/01/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2011
• 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
• Patient Age: 63 YR
• Patient Weight: 84