MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-27 for SURGN CART 9735665 STEALTH S8 PREMIUM manufactured by Medtronic Navigation, Inc.
[185224044]
Other relevant device(s) are: product id: 9735821, serial/lot #: unknown. Onsite functional and visual examination was performed by a manufacturer representative. Hardware parts were replaced and the issue was resolved. The system passed a system checkout and was returned to an operational condition. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[185224045]
Medtronic received information regarding a navigation used outside of procedure. It was reported that while performing a planned maintenance for the system, when running the ndi accuracy test, the camera failed. No patient present.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1723170-2020-01085 |
| MDR Report Key | 9888419 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-27 |
| Date of Report | 2020-04-01 |
| Date of Event | 2020-03-13 |
| Date Mfgr Received | 2020-03-30 |
| Device Manufacturer Date | 2017-03-22 |
| Date Added to Maude | 2020-03-27 |
| 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 | SURGN CART 9735665 STEALTH S8 PREMIUM |
| Generic Name | INSTRUMENT, STEREOTAXIC |
| Product Code | HAW |
| Date Received | 2020-03-27 |
| Returned To Mfg | 2020-03-26 |
| Model Number | 9735665 |
| Catalog Number | 9735665 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-03-27 |