MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S7 SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number S7

Device Problem No Display/Image (1183)

Patient Problem No Patient Involvement (2645)

Event Date 05/19/2016

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.The initial report occurred on (b)(6) 2016 and was found to be a non-reportable malfunction based on the information available at the time the event occurred.On (b)(6)2017, a retrospective review related to a capa was completed for all events where the reported malfunction was not previously associated with serious injuries; the reporting determination has been revised to consider these malfunction events reportable.A medtronic representative tested the equipment, leading to the replacement of the staff cart monitor.After the part was replaced, the hardware, software, and instruments passed the system checkout.The system was found to be fully functional.The hardware investigation found that the reported event was related to a hardware issue, specifically that a connector to the monitor was loose.This issue was documented in a medtronic navigation hardware anomaly tracking database.

Event Description

A medtronic representative reported that after the system warms up for about a minute the staff cart monitor turns white.There was no patient present when this issue was identified.

• Brand Name: STEALTHSTATION S7 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: rob edward ; 826 coal creek circle; louisville, CO 80027 ; 7208902154
• MDR Report Key: 6316390
• MDR Text Key: 67243253
• Report Number: 1723170-2017-00667
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994450944
• UDI-Public: 00613994450944
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050438
• 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
• Report Date: 02/09/2017

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: Medical Equipment Company Technician/Representative
• Device Model Number: S7
• Device Catalogue Number: 9733856
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/17/2017
• Initial Date FDA Received: 02/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2013
• 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