MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC S8 EM/ENT; INSTRUMENT, STEREOTAXIC

Model Number 9735669

Device Problem Imprecision (1307)

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

Event Date 05/13/2020

Event Type  malfunction  

Manufacturer Narrative

Other relevant device(s) are: product id: 9735736, serial/lot #: 1.2.0.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system used during a functional endoscopic sinus surgery.It was reported that there was an error/inaccuracy of more than five millimeters.When putting the instrument on the tip of the patient's nose, it looked like it was being put on the patient's lips on the screen.This was seen when using the straight suction.They used trace registration, the non-invasive tracker and flat emitter.It was stated that all instruments were inaccurate except for the registration probe.Since the inaccuracy was so large they decided to abort navigation.They ensured that the patient tracker was rigidly fixed, the registration was made carefully to have a registration accuracy of less than 1 mm and the scrub tables were placed to prevent metal interference.It was reported that the probable cause was related to the flat emitter.There was a procedure delay of less than one hour and no impact to the patient.

Manufacturer Narrative

Additional information was received: concomitant medical products' information references the main component of the system.Other relevant device(s) are: product id: 9735960, serial/lot #: (b)(4).If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

H3) a software analysis was initiated.However, the software evaluation found that a probable cause was unable to be determined.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: S8 EM/ENT
• Type of Device: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 10074333
• MDR Text Key: 191536560
• Report Number: 1723170-2020-01465
• Device Sequence Number: 1
• Product Code: PGW
• Combination Product (y/n): N
• PMA/PMN Number: K162309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9735669
• Device Catalogue Number: 9735669
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1