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

Catalog Number 9735669

Device Problem Intermittent Loss of Power (4016)

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

Event Date 07/26/2018

Event Type  malfunction  

Manufacturer Narrative

A medtronic representative went to the site to test the equipment.Testing revealed that the battery was found to be holding it¿s charge and the reported issue could not be replicated.The system then passed the system checkout and was found to be fully functional.No parts have been returned to the manufacturer for analysis.

Event Description

Medtronic received information regarding an imaging device being used for a functional endoscopic sinus surgery (fess) procedure.The issue was noted intra-perioperatively and had no impact on patient outcome.The delay in surgery was less than 1 hour.It was reported that while navigating, the system's blue light began to flash, and the system shut down on its own.The system was rebooted and the case resumed without issue.It was also noted that while in navigation admin, to open the self-test tool, the system started beeping and the power button began to flash while still connected to wall power.It was switched to another power outlet on site and the system resumed connection.It was using the same outlet as was in use in the clinical case.When the system recognized it was connected to power, the ups status showed normally.When disconnected from power, the uninterruptible power supply (ups) recognized it was on battery, but under "time until forced shutdown" showed "n/a on wall power".Self-test shows no connection to main cart touchscreen.

Manufacturer Narrative

The logs for the navigation system were reviewed by medtronic personnel.The logs showed that the software of the navigation system was functioning as designed and there were no indications of an anomaly.

• 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: peter verhey ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710
• MDR Report Key: 7799054
• MDR Text Key: 117696135
• Report Number: 1723170-2018-04134
• Device Sequence Number: 1
• Product Code: HAW
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 09/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9735669
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/26/2018
• Initial Date FDA Received: 08/20/2018
• Supplement Dates Manufacturer Received: 09/17/2018
• Supplement Dates FDA Received: 09/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2017
• 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 Age: 49 YR
• Patient Weight: 90