MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S8 EM ENT SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number 9735669

Device Problems Computer Software Problem (1112); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

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

Event Date 03/20/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information was unavailable from the site.Udi not available for this system at time of filing.No parts have been received by the manufacturer for evaluation.

Event Description

Information was received from a manufacturer representative regarding a navigation system used in an functional endoscopic sinus surgery (fess).It was reported that the a 3mm slice computed tomography (ct) exam with 56 slices was the only exam used for the procedure.Only the registration model was created.The system displayed a 'low performance' error when trouble shooting the em interface box when the instruments were being connected.The application was not restarted and the use of this system was aborted.A different navigation system was brought in to complete the procedure.There was a reported delay to the procedure of less than 1 hour due to this issue and there was no reported impact on patient outcome.

Manufacturer Narrative

Additional information: unique device identification (udi) provided.Correction: device manufacture date updated to proper value.

Manufacturer Narrative

A software investigation analysis was initiated to determine the probable cause of the issue through log analysis.Analysis found that there were no errors logged in the logs.Analysis found that the analysis was inconclusive and probable cause was unable to be determined.

Manufacturer Narrative

Patient weight and gender provided.No other patient information was available from the site.

• Brand Name: STEALTHSTATION S8 EM ENT SYSTEM
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: stephanie riley ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710 ; 7635267745
• MDR Report Key: 7409797
• MDR Text Key: 105165213
• Report Number: 1723170-2018-01554
• Device Sequence Number: 1
• Product Code: HAW
• 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: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 9735669
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2017
• 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 Weight: 68