MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION S8 EM ENT SYSTEM; INSTRUMENT, STEREOTAXIC

Model Number 9735669

Device Problem Human-Device Interface Problem (2949)

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

Event Date 08/20/2019

Event Type  malfunction  

Manufacturer Narrative

Other relevant device(s) are: product id: 9733752, serial/lot #: unknown.Patient information was unavailable from the site.No parts have been returned to the manufacturer for analysis.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation device being used for a functional endoscopic sinus surgery (fess).It was reported that the site¿s system was showing localizer not connected.The site brought in their other system and the issue was the same.The site then noticed that the pins in the lemo connector were bent.The site used a different emitter to continue their case.There was a surgical delay of less than 1 hour due to this issue, and there was no impact on patient outcome.

Manufacturer Narrative

The manufacturer representative went to the site to test the navigation system.The reported issue was confirmed and the emitter was replaced.Eval code method is associated with this analysis eval code result is associated with this analysis.Eval code conclusion is associated with this analysis.The emitter was returned for analysis and is under investigation at this time.Eval code method is associated with this statement, eval code result is associated with this statement, eval code conclusion is associated with this statement.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

The emitter (lot# 603000419) was returned for analysis.Analysis found that the returned flat emitter had a bent pin 7.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.If information is provided in the future, a supplemental report will be issued.

• Brand Name: STEALTHSTATION S8 EM ENT SYSTEM
• Type of Device: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 8940345
• MDR Text Key: 155959821
• Report Number: 1723170-2019-04669
• Device Sequence Number: 1
• Product Code: PGW
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/28/2019

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 Model Number: 9735669
• Device Catalogue Number: 9735669
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/20/2019
• Initial Date FDA Received: 08/28/2019
• Supplement Dates Manufacturer Received: 09/12/2019; 10/01/2019
• Supplement Dates FDA Received: 09/26/2019; 10/28/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2017
• 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