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

Model Number 9735669

Device Problems Mechanical Problem (1384); Output Problem (3005)

Patient Problem No Patient Involvement (2645)

Event Date 04/28/2020

Event Type  malfunction  

Manufacturer Narrative

Other relevant device(s) are: sfw kit 9735736 stealth s8 ent eu-sc.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system.It was reported by the site that when they load exams onto the system, they all showed up as unknown.The site did not know which patient exam they needed for the next day, so they attempted to reload the disc.After reloading the exam, a database error message appeared on the screen.There was no patient present.Technical services (ts) was able to troubleshoot over the phone with the site.All exams listed as imported since a past date were listed as "unknown" patient name with one exam per patient.The date was set on the system to a specific date.Unknown when that change occurred, or if it was set incorrectly from the start.Date was updated to correct date.Technical services (ts) had the site delete all "unknown" exams that were older than the exam imports for the patients in the upcoming cases.The site then renamed all the "unknown" entries for the upcoming cases, in case they were unable to import.One of the exams would not rename and was deleted, in case it was causing the database problems.The site tried importing again.When exam discs were inserted into the system, the exam list on the "media" screen for the import shows the patient name and mrn.When they are imported, every exam is listed as "transfer failed", but the exams do import completely.However, each exam imports under a different patient entry and all have the name as "unknown".The site said this started happening a few months ago.The site then combined all "unknown" exams from a single exam disc into a new patient entry, then renamed as the actual patient name for use by the site in the upcoming case.The site then moved to the next exam disc and repeated the process.The site stated they will be deleting all older (renamed) exams off of the system when completed.

• 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: 10013148
• MDR Text Key: 189450241
• Report Number: 1723170-2020-01336
• 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: Nurse
• Type of Report: Initial
• Report Date: 04/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2020
• 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
• Date Manufacturer Received: 04/28/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/19/2018
• 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