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

Model Number 9736242

Device Problem Device Sensing Problem (2917)

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

Event Date 12/01/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system used during a functional endoscopic sinus surgery (fess) procedure.It was reported that the site was having issues verifying their straight suction while using the flat emitter.The site switched to the side emitter and still had some issue with the longer instrumentation.The site needed to move the side emitter very close for patient tracking.The surgeon decided to switch to a different system.After the case it was confirmed that the site had left the flat emitter under the patient when they moved to the side emitter.Even with the flat emitter unplugged, this could cause some interference on the system.Testing the bed also confirmed that there needed to be additional padding underneath the flat emitter to lower the metal interference values.When testing, it was not easy to verify the straight suction when the demo head was resting on the large donut.Technical services recommended off setting the non-invasive patient tracker (nipt) to avoid hitting the electromagnetic (em) threshold with longer instrumentation and this worked.The probable cause was due to metal interference/the operating room set-up.There was a delay of less than one hour and no impact to the patient.Additional information was received.It was reported that the metal interference issue was affecting both verification and tracking.It was noted that it was not communicated to the field that when switching from a flat emitter to a side emitter that it is necessary to remove the unplugged flat emitter from under the patient.The unplugged flat emitter is essentially a slab of metal when the side emitter is plugged in.The tracking issue was able to be resolved by switching the operating room bed that the site uses and the flat and side emitter were functioning properly.This was done after the procedure.The site brought in another system to finish the case as the tracking issue was not resolved and the representative then tested the original system.

• Brand Name: STEALTHSTATION FLEXENT
• 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: tricha miles ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635140379
• MDR Report Key: 11057774
• MDR Text Key: 226033520
• Report Number: 1723170-2020-03379
• Device Sequence Number: 1
• Product Code: PGW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200723
• 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
• Report Date: 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9736242
• Device Catalogue Number: 9736242
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2020
• Was Device Evaluated by Manufacturer?: No
• 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: 54 YR
• Patient Weight: 67