MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LITTLETON) O-ARM O2 IMAGING SYSTEM; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Catalog Number BI70002000-G27

Device Problems Break (1069); Difficult to Open or Close (2921)

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

Event Date 04/17/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information was unavailable from the site.A medtronic representative went to the site to test the equipment.The representative found that the user opened the door in the incorrect order, resulting in over torquing the winch and breaking the door cable slides.The broken door slide screws and door winch were replaced.The imaging system then passed the system checkout and was found to be fully functional.The suspected door winch was returned for analysis, however results are not yet available.

Event Description

Medtronic received information regarding an imaging device being used for a spinal fusion procedure.It was reported that the imaging system was stuck around the procedure.The site attempted to open the door manually and heard something snap.The system was not moving at all.The manufacturing representative that was on site confirmed that the site had skipped the first step when manually opening the door and caused internal damage.There was no reported impact on patient outcome.There was a reported delay to the procedure of less than 1 hour due to this issue.

Event Description

Due to the reported issue, medtronic imaging and navigation were aborted.The surgery was also aborted.

Event Description

It was clarified that the imaging system was stuck around the patient.Additionally, the surgery was completed according to a manufacturer representative who was on site to assist in the removal of the imaging system.The surgery was not aborted, but navigation and imaging were aborted.

Manufacturer Narrative

The winch assembly for the imaging system was returned to the manufacturer for evaluation.Testing found that there was wear on the motor drive gear.

• Brand Name: O-ARM O2 IMAGING SYSTEM
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• 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: peter verhey ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710 ; 7635267745
• MDR Report Key: 7509928
• MDR Text Key: 108143038
• Report Number: 1723170-2018-02017
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Radiologic Technologist
• Device Catalogue Number: BI70002000-G27
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/17/2018
• Initial Date FDA Received: 05/14/2018
• Supplement Dates Manufacturer Received: 06/22/2018; 07/12/2018; 07/23/2018
• Supplement Dates FDA Received: 07/06/2018; 07/13/2018; 08/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2016
• 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