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

Model Number BI70002000

Device Problems Device Damaged Prior to Use (2284); Material Deformation (2976); Physical Resistance/Sticking (4012)

Patient Problem No Patient Involvement (2645)

Event Date 01/04/2019

Event Type  malfunction  

Manufacturer Narrative

A medtronic representative went to the site to test the equipment.Testing revealed that the x-drive was not smoothly moving and the docking pins were destroyed from the crating.The door would not close.The x-stage cover was replaced and the system was re-homed.The system was able to move all directions.The system was a little uneasy when extending and retracting.The representative inspected everything associated with the x-movement and was not able to find anything loose, broken, or misaligned.It was noted that the system was damaged during transport.The system was functional.No parts have been received by the manufacturer for evaluation.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding an imaging system.It was reported while the system was in shipping, the x-stage cover and caster mounts were damaged and needed to be replaced.There was no patient present when this issue was identified.

Manufacturer Narrative

The docking pin and top caster mount were returned to the manufacturer.However, analysis has not been completed.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.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 in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees 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 reporting pursuant to part 803.Medtronic objects to the use of these words and others like it 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.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.

Manufacturer Narrative

The docking pins were returned to the manufacturer for analysis.Visual inspection found that the docking pins acquired impact damage to the top and sides of the pins.The pins were physically damaged.The castor mount was returned to the manufacturer for analysis.Analysis found that all threads and recessed bolt holes were in tacked and functional.It failed visual inspection; there were light surface rough spots and small scratched on the top of the mount.The caster mount had cosmetic damage.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: O-ARM O2 IMAGING SYSTEM
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC (LITTLETON); 300 foster st; littleton MA 01460
• MDR Report Key: 8278879
• MDR Text Key: 134184953
• Report Number: 3004785967-2019-00142
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 00643169639683
• UDI-Public: 00643169639683
• Combination Product (y/n): N
• PMA/PMN Number: K151000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 03/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BI70002000
• Device Catalogue Number: BI70002000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2019
• Date Manufacturer Received: 02/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1