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

Catalog Number 9735669

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Mechanical Problem (1384); Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913)

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

Event Date 03/05/2018

Event Type  malfunction  

Manufacturer Narrative

Unique device identifier (udi) is unavailable.Device manufacture date is unavailable.A medtronic representative went to the site to test the equipment.The representative was unable to replicate the reported issue.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional.

Event Description

A manufacturer representative reported that, while in a functional endoscopic sinus surgery (fess), the touchscreen of the navigation system lost functionality and then the system was unresponsive to prompts from the user.It was reported that the issue occurred during registration and that the mouse could move in the software but clicks did not respond.Restarting the navigation system resolved the reported issue.There was no reported impact on patient outcome.No additional information was provided.

Manufacturer Narrative

Additional information: device manufacture date and unique device identification (udi) provided.The logs for the navigation system were reviewed by medtronic personnel.However, the logs provided no additional insight into the probable cause of the anomaly.

Manufacturer Narrative

A software analysis was initiated to determine the probable cause of the issue through log analysis.Analysis found that the reported event was related to a software issue.This issue was documented in a medtronic navigation software anomaly tracking database.

Manufacturer Narrative

Other relevant device(s) are: product id: 9735736, serial/lot #: unknown, ubd: unknown, udi# unknown.The codes listed are applicable to the event upon further review.If information is provided in the future, a supplemental report will be issued.

• 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: peter verhey ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710
• MDR Report Key: 7371854
• MDR Text Key: 103530326
• Report Number: 1723170-2018-01323
• Device Sequence Number: 1
• Product Code: HAW
• 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,user f
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 9735669
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2017
• 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: 29 YR
• Patient Weight: 113