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 02/27/2018

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.The suspect splitter has been received by the manufacture for evaluation.As reported, the returned splitter had no output when connected to a known good system.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, when setting up for a case the site was unable to get video on the navigation system.During troubleshooting, representative reported that the surgeon monitor was not.The surgeon monitor was unplugged and plugged in a monitor for another navigation system and the other monitor was working.Then the staff cart monitor was not working.Video spliter was bypassed for the staff cart monitor and the monitor began to work.Video splitter was swapped from other navigation system and both surgeon and staff cart monitors were working.Surgeon monitor cable was plugged into non-working surgeon monitor and video appeared.The subsequent procedure was completed with one of the external monitors.There was no patient present at the time of the issue.

Manufacturer Narrative

The suspect cable has been received by the manufacturer for analysis.As returned, the cable was failing a continuity test.It was found that there were broken tabs on the fischer connector not allowing the outer shell to seat, properly aligning the pins to the key.After establishing the correct orientation, the cable passed a continuity test with no opens or shorts.However, due to the damaged connector, the fischer connector cannot be re-assembled correctly rendering the cable unusable.A new cable was shipped to the site.A medtronic representative went to the site to test the equipment.The navigation system then passed the system checkout and was found to be fully functional.

• 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: sarah olhoft ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902515
• MDR Report Key: 7363312
• MDR Text Key: 103279351
• Report Number: 1723170-2018-01250
• 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,user f
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 04/05/2018

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: Physician
• Device Model Number: S7
• Device Catalogue Number: 9733856
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/27/2018
• Initial Date FDA Received: 03/22/2018
• Supplement Dates Manufacturer Received: 03/26/2018
• Supplement Dates FDA Received: 04/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2016
• 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