MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC (LITTLETON) BASE OARM BI70000028230 SYS 230V; INSTRUMENT, STEREOTAXIC

Model Number BI70000028230

Device Problems Calibration Problem (2890); Positioning Problem (3009)

Patient Problem No Patient Involvement (2645)

Event Date 07/21/2020

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: sw app 9735762 stealth s8 app, software version: 1.2.0.A manufacturer representative went to the site to test the equipment.It was reported that the gantry motion controller and ins tall firmware were replaced.The imaging system then passed the system checkout and was found to be fully functional.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding an imaging device being used outside of procedure.It was reported that the image acquisition system (ias) does not fully calibrate motion.When they turned on the ias on, they were required to "hold m button for motion calibration".After that, they pressed and hold the m button and the machine can move forward/backward, left/right, up/down, but it becomes stuck when it tries to tilt.After that, they tried to open/close the door, but would get no response.There was no patient present when this issue was identified.Troubleshooting showed that manual door open/close failed.Remote desktop to tech console showed gantry status as verified and its not home status.They tried to invalid home but is still stuck.It is suspected that the gantry motion controller to be damaged.

Manufacturer Narrative

Analysis on the returned motion control has an electrical failure that was found when test on a test system.The system did not initialize and the motion did not ready.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: BASE OARM BI70000028230 SYS 230V
• Type of Device: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC (LITTLETON); 300 foster st; littleton MA 01460
• MDR Report Key: 10364304
• MDR Text Key: 201670213
• Report Number: 3004785967-2020-00905
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• PMA/PMN Number: K050996
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 09/22/2020

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: No Information
• Device Model Number: BI70000028230
• Device Catalogue Number: BI70000028230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2020
• Initial Date Manufacturer Received: 07/21/2020
• Initial Date FDA Received: 08/04/2020
• Supplement Dates Manufacturer Received: 09/02/2020; 09/08/2020
• Supplement Dates FDA Received: 09/02/2020; 09/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10...."