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

Model Number 9735665

Device Problems Imprecision (1307); Audible Prompt/Feedback Problem (4020)

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

Event Date 06/18/2019

Event Type  malfunction  

Manufacturer Narrative

Other relevant device(s) are: product id: 9735736, serial/lot #: unknown.A medtronic representative went to the site to test the equipment.The navigation system passed the system checkout and was found to be fully functional.No parts were replaced on the system.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 there was an alleged inaccuracy during the case.It was also reported that the site was doing a trace registration and the minimum trace bar was filled but the software did not beep to indicate the minimum trace was complete.The medtronic representative had the surgeon remove the instrument from the field, bring it back and trace more and the system finally beeped to show minimum trace completed.The site was able to successfully pass a trace registration, but when verifying accuracy the probe was 5-7mm anterior of the patient¿s skin when touching the nose.The site re-registered and when verifying accuracy the probe was not 5mm superior to the nose.The site switched to another medtronic navigation system but the same inaccuracy occurred.The site chose to abort navigation.There was a surgical delay of less than 1 hour due to this issue, and there was no impact on patient outcome.The medtronic representative who was present for the case mentioned that the patient exam was not optimal and the patient had a lot of deep grooved wrinkles on the face.It was later reported that the incorrect patient had been loaded, so the incorrect patient exam was in use.

Manufacturer Narrative

Device evaluation: an additional software analysis was completed for the minimum trace issue (not the alleged inaccuracy issue).However, the software analysis was unable to determine probable cause without further information since the on-going investigation proved to be inconclusive based on the information provided.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Correction: other relevant device(s) are: product id: 9735736 (software version: 1.2.0).Device evaluation: a software analysis was completed.It was determined that the behavior described is the intended behavior of the software.The software was functioning as designed.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Event Description

Additional information was received.It was reported that at the last case the issue with minimum trace did not occur.

• Brand Name: STEALTHSTATION S8 PREMIUM 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: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 8791772
• MDR Text Key: 151117245
• Report Number: 1723170-2019-04098
• Device Sequence Number: 1
• Product Code: PGW
• UDI-Device Identifier: 00643169722187
• UDI-Public: 00643169722187
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/17/2019

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: 9735665
• Device Catalogue Number: 9735665
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/18/2019
• Initial Date FDA Received: 07/15/2019
• Supplement Dates Manufacturer Received: 07/18/2019; 09/11/2019; 10/01/2019
• Supplement Dates FDA Received: 07/30/2019; 09/17/2019; 10/17/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2019
• 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: 68 YR
• Patient Weight: 108