MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-31 for STEALTHSTATION S8 EM ENT SYSTEM 9735669 manufactured by Medtronic Navigation, Inc.
[186539970]
Site was not requesting service. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[186539971]
Medtronic received information regarding a navigation system being used for a functional endoscopic sinus surgery (fess) procedure. A side and underhead emitter were used for the procedure. Registration and first operation steps were performed with the same setting with the underhead emitter. It was also reported registration was good with an overhead accuracy of less than 2mm. The first deviation (interpreted as inaccuracy) occurred approximately 10 minutes after the start of the operation in the lower area of the nasal floor. The inaccuracy was estimated to be 4. 8mm (confirmed via provided images). When switching to the side emitter, the inaccuracy was a lot less in the same area of the nasal floor (approximately 1. 4mm confirmed via provided images). The issue did not result in a procedure delay. The procedure was completed without aborting navigation. There was no impact on patient outcome.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1723170-2020-01116 |
| MDR Report Key | 9904095 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-02 |
| Date Mfgr Received | 2020-03-03 |
| Device Manufacturer Date | 2018-02-09 |
| Date Added to Maude | 2020-03-31 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | STACY RUEMPING |
| Manufacturer Street | 7000 CENTRAL AVENUE NE RCW215 |
| Manufacturer City | MINNEAPOLIS MN 55432 |
| Manufacturer Country | US |
| Manufacturer Postal | 55432 |
| Manufacturer Phone | 7635260594 |
| Manufacturer G1 | MEDTRONIC NAVIGATION, INC |
| Manufacturer Street | 826 COAL CREEK CIRCLE |
| Manufacturer City | LOUISVILLE CO 80027 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80027 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STEALTHSTATION S8 EM ENT SYSTEM |
| Generic Name | INSTRUMENT, STEREOTAXIC |
| Product Code | HAW |
| Date Received | 2020-03-31 |
| Model Number | 9735669 |
| Catalog Number | 9735669 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC NAVIGATION, INC |
| Manufacturer Address | 826 COAL CREEK CIRCLE LOUISVILLE CO 80027 US 80027 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-31 |