MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION¿ S8 SYSTEM; EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT

Model Number 9735669

Device Problems Computer Operating System Problem (2898); Human-Device Interface Problem (2949)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/06/2022

Event Type  malfunction  

Event Description

Medtronic received information regarding a navigation system being used during a functional endoscopic sinus surgery (fess).It was reported that the system was lagging while registering and was taking a long time to collect the minimum trace points.Once all of the points were collected, the system seemed inaccurate.It was reported that the surgeon stated that although the registration number and spheres of accuracy showed that he should be within 2mm of accuracy, he was not accurate.He could not obtain an accurate registration that he felt confident with.There was a surgical delay of 5-10 minutes and no impact on the patient outcome.

Manufacturer Narrative

Patient information was requested but is not available at this time.Other relevant device(s) are: product id: 9735737, version #: (b)(6).A medtronic representative went to the site to test the equipment.Testing revealed that the system was performing as intended and no issues were found.If information is provided in the future, a supplemental report will be issued.

• Brand Name: STEALTHSTATION¿ S8 SYSTEM
• Type of Device: EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT
• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 14251930
• MDR Text Key: 290457414
• Report Number: 1723170-2022-00656
• 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: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• 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: 04/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2019
• 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: 20 YR
• Patient Sex: Female