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

Model Number BI70002000

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/12/2021

Event Type  malfunction  

Manufacturer Narrative

A medtronic representative went to the site to test the system.The representative found damage caused by user.The lower louvre cover was bent outward, showing that it was caught on something, most likely when pulling away from a surgical table.This caused damage to the 2 fans that are attached to that cover.It also caused damage to the v-groove rollers that the internal gantry spins on.The representative replaced lower louvre cover, fans, and damaged v-groove rollers.The system was now ready for use.Information references the main component of the system.Other relevant device(s) are: product id: kit svc o2 bi71000452 cover pos louvre unknown, ubd: , udi#:unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding an imaging system being used outside of a procedure.It was reported that the system was making a "screeching" noise.This was all the information that was provided.There was was no patient present.

Manufacturer Narrative

H3, h6: the kit svc o2 bi71000452 cover pos louvre (rev.3 - s/n : (b)(4)) was returned for analysis.Analysis found that the complaint was confirmed.Visual inspection confirmed that the louver cover was bent and multiple fan blades were physically broken/missing from fan assembly.Evaluation codes that apply: b01, c07, d02 the svc kit bi71000105 v groove rollers (rev.3 - s/n: (b)(4)) was returned for analysis.Analysis found that the complaint was confirmed.Visual inspection showed that the returned groove roller bearings were worn and in used condition.Due to wear they did not spin smoothly causing noise and excess friction.The groove rollers were worn.The hardware investigation found that the reported event was related to a hardware issue.This issue was documented in a medtronic navigation hardware anomaly tracking database.Evaluation codes that apply: b01, c07, d02 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: 12425913
• MDR Text Key: 271701159
• Report Number: 3004785967-2021-01071
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 00763000132378
• UDI-Public: 00763000132378
• Combination Product (y/n): N
• PMA/PMN Number: K200074
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/12/2021

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: BI70002000
• Device Catalogue Number: BI70002000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2021
• Initial Date Manufacturer Received: 08/12/2021
• Initial Date FDA Received: 09/03/2021
• Supplement Dates Manufacturer Received: 09/17/2021
• Supplement Dates FDA Received: 10/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1