SURGN CART 9735665 STEALTH S8 PREMIUM Adverse Event — Malfunction (MDR 1723170-2020-01319)
SURGN CART 9735665 STEALTH S8 PREMIUM Adverse Event — Malfunction (MDR 1723170-2020-01319) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: SURGN CART 9735665 STEALTH S8 PREMIUM; Generic name: INSTRUMENT, STEREOTAXIC; Manufacturer: MEDTRONIC NAVIGATION, INC.
| Device | SURGN CART 9735665 STEALTH S8 PREMIUM |
|---|---|
| Generic name | INSTRUMENT, STEREOTAXIC |
| Manufacturer | MEDTRONIC NAVIGATION, INC |
| Report number | 1723170-2020-01319 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, HEALTH |
| Narrative | H3: A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. TESTING REVEALED THAT THE SYSTEM WAS PERFORMING AS INTENDED. THE SYSTEM PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NO |
| Source | openFDA MAUDE (device adverse events) |
🔍 Search all device adverse events →
$1999/mo
Try DeviceEvents →