MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-28 for NAVIGATOR manufactured by Dilon Technologies, Inc..
[134210218]
Navigator stopped calibrating during the procedure and the surgeon could not find the cancer lymph nodes with the guidance of the navigator.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8280963 |
| MDR Report Key | 8280963 |
| Date Received | 2019-01-28 |
| Date of Report | 2018-12-21 |
| Date of Event | 2018-12-07 |
| Report Date | 2018-12-21 |
| Date Reported to FDA | 2018-12-21 |
| Date Reported to Mfgr | 2019-01-28 |
| Date Added to Maude | 2019-01-28 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NAVIGATOR |
| Generic Name | PROBE, UPTAKE, NUCLEAR |
| Product Code | IZD |
| Date Received | 2019-01-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DILON TECHNOLOGIES, INC. |
| Manufacturer Address | 12050 JEFFERSON AVE STE. 340 NEWPORT NEWS VA 23606 US 23606 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-01-28 |