MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC (LITTLETON) O-ARM 1000 IMAGING SYSTEM; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE

Model Number 9732719

Device Problems Positioning Problem (3009); Application Program Freezes, Becomes Nonfunctional (4031)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/22/2020

Event Type  malfunction  

Manufacturer Narrative

Other relevant device(s) are: product id: bi71000537 and product id: bi71000488.A medtronic representative went to the site to test the equipment.The manufacturer representative replaced the gantry motion controller.It was also noted the door winch needed replacement which was then replaced under another product event file.No parts have been received by the manufacturer for further analysis.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding an imaging system being used for a sacroiliac and thoracolumbar procedure.It was reported the site was unable to open the gantry because the pendant was not working as intended.It was also noted the open button felt different from the other buttons.Technical services (ts) instructed the site to use the yellow release button on the side and the closed button on the pendant to get it to open.This issue occurred post-operatively and did not cause any surgical delay.There was no reported impact on patient outcome.

Manufacturer Narrative

Additional information: product id: bi70000023, lot/serial: rev.5 : s/n (b)(4).Product id: bi71000537, lot/serial: rev.2 : s/n 101785575 h3, h6: the gantry motion controller board was returned to medtronic for analysis.Testing was conducted and the issue was unable to be reproduced.There were no failures found.Fdm b01, fdr c19, and fdc d14 are applicable to the controller board analysis.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

H3: the pendant was returned to the manufacturer.Functional testing confirmed the reported issue and found the pendant was stuck in initializing.This issue was caused by an electrical failure.The gantry motion controller has been received by the manufacturer, however analysis results were not available at the time of filing.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.

Event Description

Additional information was received stating the most likely cause was the gantry controller.

• 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 st; littleton MA 01460
• MDR Report Key: 10752336
• MDR Text Key: 214150444
• Report Number: 3004785967-2020-01290
• Device Sequence Number: 1
• Product Code: OXO
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 12/09/2020

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: Health Professional
• Device Model Number: 9732719
• Device Catalogue Number: 9732719
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/29/2020
• Initial Date Manufacturer Received: 10/22/2020
• Initial Date FDA Received: 10/28/2020
• Supplement Dates Manufacturer Received: 10/29/2020; 11/18/2020
• Supplement Dates FDA Received: 11/16/2020; 12/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1