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

Catalog Number 9735665

Device Problems Device Stops Intermittently (1599); Communication or Transmission Problem (2896)

Patient Problem No Patient Involvement (2645)

Event Date 05/23/2018

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.External main to camera, internal to main cart cable and internal to camera cart cable have been shipped however resolution has not been confirmed yet.The parts have been received by the manufacturer for evaluation.The returned external main to camera, internal to main cart cable and internal to camera cart cable were found to be in good condition and passed continuity test with no opens or shorts detected.No fault found.

Event Description

Medtronic received information regarding a navigation system.It was reported that the main cart and camera cart were not communicating, but the interconnected cable was providing power to the camera cart.A manufacturer representative connected an ethernet cable internally between the two carts and was able to establish connection.The representative reported that when they plugged in the camera cart to cart cable another time, the connection was established briefly, but then did not communicate.There was no patient present when this issue was identified.

Manufacturer Narrative

A medtronic representative went to the site to test the equipment.Testing revealed that the external, internal and camera communication cables were replaced to restore functionality.The system then passed the system checkout and was found to be fully functional.

• Brand Name: STEALTHSTATION S8 PREMIUM 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 ; 7208902515
• MDR Report Key: 7614444
• MDR Text Key: 111681362
• Report Number: 1723170-2018-02860
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00643169722187
• UDI-Public: 00643169722187
• 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
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 09/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 9735665
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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