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

Model Number 9735669

Device Problem Mechanical Problem (1384)

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

Event Date 01/30/2020

Event Type  malfunction  

Manufacturer Narrative

The system was serviced in the field and no failure was found.The system passed all checkouts and was performing as intended.Other relevant device(s) are: order part: sfw kit, 9735736, stealth s8 ent eu-sc software: sw app 9735762, stealth s8 app.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 (fess).It was reported that the site was able to register the patient, but when they went into navigate the instrumentation was not showing as tracking in the tracking view.The instrumentation was green in the emitter details.The instrumentation was re-plugged in and this resolved the issue.There was a procedure delay of less than one hour and no impact to the patient.

Manufacturer Narrative

A software investigation analysis was initiated to determine the root cause of the reported event.Analysis found that there was no indication that a software anomaly contributed to the reported behavior.The logs showed faults that suggested electromagnetic interference.The software evaluation found that the root cause was unable to be determined.If information is provided in the future, a supplemental report will be issued.

• Brand Name: S8 ENT
• Type of Device: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 9659867
• MDR Text Key: 177647526
• Report Number: 1723170-2020-00332
• Device Sequence Number: 1
• Product Code: PGW
• UDI-Device Identifier: 00643169838918
• UDI-Public: 00643169838918
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2020
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 70 YR