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

Catalog Number 9735665

Device Problems Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 01/29/2018

Event Type  malfunction  

Manufacturer Narrative

A medtronic representative went to the site to test the equipment.The representative was unable to replicate the reported issue.It was reported that the alignment laser on the camera was not firing.The laser connection was then found to be bent.The camera handle was then replaced to resolve the laser firing issue.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional.The handle was returned to the manufacturer for evaluation.It was reported that the connector plug was bent, resulting in the reported issue.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 a procedure, the fault light on the camera of the navigation system was illuminated at installation.It was reported that cables on the navigation system were reseated and restarting the navigation system did not restore functionality.There was no patient present when this issue was identified.No additional information was provided.

• 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 ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710
• MDR Report Key: 7289134
• MDR Text Key: 100905530
• Report Number: 1723170-2018-00818
• 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,user f
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 02/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 9735665
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2017
• 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