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

Catalog Number BI70002000

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/01/2017

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 reported that the winch assembly on the imaging system gantry was damaged due to shear and thus replaced.Additionally, the door cable slides were damaged and replaced by the medtronic representative.The imaging system then passed the system checkout and was found to be fully functional.The suspect winch and slides were returned to the manufacturer for evaluation.Both components failed visual inspection due to damaged components.

Event Description

A site radiologic technologist (rt) reported that, while in a spinal fusion, the imaging system gantry door would not open when prompted by the user.The site attempted to manually open the door, but a loud noise was heard emitting from the imaging system.The reported issue occurred when the site was done using the imaging system in the procedure.The site then removed the patient from the imaging system gantry area following the procedure.There was a reported delay to the procedure of less than 1 hour due to this issue.There was no impact on patient outcome.No additional information was provided.

Manufacturer Narrative

The suspect cover was returned to the manufacturer for evaluation.Visual inspection found scratches on the cover, however the reported issue could not be replicated.

• 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 ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710
• MDR Report Key: 6599615
• MDR Text Key: 76248360
• Report Number: 1723170-2017-02230
• 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: Radiologic Technologist
• Type of Report: Initial,Followup
• Report Date: 07/05/2017

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/01/2017
• Initial Date FDA Received: 05/30/2017
• Supplement Dates Manufacturer Received: 06/07/2017
• Supplement Dates FDA Received: 07/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/24/2015
• 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