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

Catalog Number 9735669

Device Problem Erratic or Intermittent Display (1182)

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

Event Date 07/17/2018

Event Type  malfunction  

Manufacturer Narrative

Onsite functional and visual examination was performed by a manufacturer representative.The batteries and the uninterruptible power supply (ups) were replaced and the issue was resolved.The system passed a system checkout and the system was returned to an operational condition.

Event Description

Medtronic received information regarding a navigation system being used during a functional endoscopic sinus surgery (fess) procedure.It was reported that the system monitor suddenly switched to "no input detected" and would not respond.Issue occurred intra/peri-operatively.There was no reported impact to patient outcome.A manufacturer representative was on site troubleshooting after the surgery.When he turned the system off it would not boot at all.

Manufacturer Narrative

The battery was returned to the manufacturer for analysis.Analysis found that battery measured normal voltage.No fault found.The main cart ups was returned to the manufacturer for analysis.Analysis found that during initial testing lights were on when connected to outlet.Battery light flashed when battery was attached.When powered on, all lights were activated and all outputs measured normal voltages.However, when the ups was left running for an hour, it would not power down when the power switch was pressed.Unplugging and plugging back in but ups would not turn on.Analysis found that the reported event was related to a electrical issue.

• 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: prashanth gali ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902515
• MDR Report Key: 7776881
• MDR Text Key: 116896303
• Report Number: 1723170-2018-03978
• 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: 09/19/2018

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/17/2018
• Initial Date FDA Received: 08/13/2018
• Supplement Dates Manufacturer Received: 09/17/2018
• Supplement Dates FDA Received: 09/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2017
• 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: 45 YR
• Patient Weight: 60