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

Catalog Number 9735669

Device Problem Imprecision (1307)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/14/2017

Event Type  malfunction  

Manufacturer Narrative

Correction: correct manufacture date received.

Manufacturer Narrative

The manufacturer conducted a hardware review and was unable to confirm the reported issue. No further action required.

Manufacturer Narrative

A medtronic representative went to the site to test the equipment. The representative was unable to replicate the reported issue. The hardware, software, and instruments passed the system checkout. The system was found to be fully functional. The archive used in the procedure was sent to medtronic for evaluation. When loaded on a known operational navigation system, it was noted that the exams were not compatible. The navigation system displayed that the exams were not to protocol, as the slicing and thickness were higher than recommended values. Also, 6 of 8 datasets lacked a proper amount of slices.

Event Description

A medtronic representative reported that, while in an orbital decompression, an imprecision was observed once the site went sterile for the procedure. It was reported that registration and verification was successful when non-sterile. Once draped, the imprecision was observed. The imprecision as noted to be between 4-5 millimeters, it was noted that the malleable suction was accurate medially when entering the sinus cavity through the eye. The surgeon opted to complete the procedure without the use of the navigation system. The surgeon opted to complete the procedure without the use of the imaging system. There was a reported delay to the procedure of less than 1 hour due to this issue. No additional information was provided.

• 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: 7118243
• MDR Text Key: 103035944
• Report Number: 1723170-2017-05079
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date: 07/30/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 9735669
• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse