MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-06-25 for EXABLATE 4000 SYS004000 manufactured by Insightec.
| Report Number | 9615058-2019-00008 |
| MDR Report Key | 8730697 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-06-25 |
| Date of Report | 2019-06-25 |
| Date of Event | 2019-05-28 |
| Date Mfgr Received | 2019-05-29 |
| Device Manufacturer Date | 2013-03-18 |
| Date Added to Maude | 2019-06-25 |
| 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 | MS. MEITAL TRANK |
| Manufacturer Street | 5 NACHUM HETH |
| Manufacturer City | TIRAT CARMEL, 39120 |
| Manufacturer Country | IS |
| Manufacturer Postal | 39120 |
| Manufacturer G1 | INSIGHTEC |
| Manufacturer Street | 5 NACHUM HETH |
| Manufacturer City | TIRAT CARMEL, ISRAEL |
| Manufacturer Country | IS |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EXABLATE 4000 |
| Generic Name | MR-GUIDED FOCUSED ULTRASOUND SYSTEM |
| Product Code | POH |
| Date Received | 2019-06-25 |
| Model Number | 4000 |
| Catalog Number | SYS004000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INSIGHTEC |
| Manufacturer Address | 5 NACHUM HETH STREET TIRAT CARMEL 39120 IS 39120 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2019-06-25 |