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 Mechanical Problem (1384); Failure to Fire (2610); Noise, Audible (3273)

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

Event Date 07/24/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information not provided due to japanese patient privacy regulations.A medtronic representative went to the site to test the equipment.Testing revealed that after the standalone board and x relay were replaced, the system functioned as intended.The imaging system then passed the system checkout and was found to be fully functional.Missing device manufacture date.

Event Description

Medtronic received information regarding an imaging system being used during a sacroiliac and thoracolumbar procedure.It was reported that during the operation, the imaging system and navigation were used.Three (3)d image was taken and transferred normally twice.In the end, in order to confirm the setting condition of the screws, when an attempt was made to take 3d image, stand alone mode was indicated on the panel of image acquisition system (ias).The central x-ray part was showed as indicator.When the image acquisition system (ias) and mobile viewing station (mvs) were rebooted, an abnormal noise sounded like ¿gee¿ was heard and the x-ray indicator was not in ¿on¿ status.The use of the imaging system was aborted and the procedure was completed with no issue.This occurred intra/peri-operatively with no delay to surgical time.There was no reported impact to patient outcome.

Manufacturer Narrative

The standalone pcb board was returned to the manufacturer for analysis.Analysis found that the issue could be recreated.The standalone pcb board passed visual inspection, but failed bench testing.Standalone pcb powers up, all ac / dc voltages are present, both the fans are on.The 380vdc, 15vdc, and all leds are on.However, the vac is measured at 68vac while it suppose to measure at a round 110vac.Relay passed performance test.Varistor measured open, and both returned fuses are good.Standalone board failed due to low vac reading.Analysis found that the reported event was related to an electrical issue.If information is provided in the future, a supplemental report will be issued.

• 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. (LITTLETON); 300 foster street; littleton MA 01460
• Manufacturer Contact: maxwell roth ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710
• MDR Report Key: 7794037
• MDR Text Key: 117573640
• Report Number: 1723170-2018-04096
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K050996
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BI-700-00027-120
• Device Catalogue Number: 9732719
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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