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

Catalog Number 9735667

Device Problems No Display/Image (1183); Display or Visual Feedback Problem (1184)

Patient Problem No Patient Involvement (2645)

Event Date 03/14/2018

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.A medtronic representative went to site to test the equipment.Representative reported that connecting power from main cart monitor to camera cart monitor did not resolve the issue and the monitor remained powered off.The self test utility showed the surgeon cart monitor with green status.Monitor was replaced which resolved the issue.The suspect monitor has been received by the manufacturer for evaluation.The returned monitor was tested and when the power was applied the state of the monitor did not change.Led indicator would not light.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.

Event Description

A medtronic representative reported that while outside of procedure, the camera cart monitor of the imaging system was displaying black.There was no power light on the bottom right corner but the touch functionality was working.There was no patient present at the time of the issue.

Manufacturer Narrative

Unique device identification (udi) provided and device manufacturing date updated to proper value.

Manufacturer Narrative

Device code was corrected.If information is provided in the future, a supplemental report will be issued.

• Brand Name: STEALTHSTATION S8 PLUS 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: heather davis ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902515
• MDR Report Key: 7399007
• MDR Text Key: 104473268
• Report Number: 1723170-2018-01454
• 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,user f
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date: 06/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 9735667
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2017
• 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