MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-05-23 for EXABLATE 4000 SYS004000 manufactured by Insightec.
[145905357]
The retrospective analysis has not indicated any technical failures or erroneous operation of the system. Treatment parameters were in line with typical range. The system performance was found to be to spec and as expected. No new risk recognized and current mitigations to the above risk were in effect.
Patient Sequence No: 1, Text Type: N, H10
[145905358]
In brain treatment of essential tremor, the patient reported lip numbness during the course of treatment. The lip numbness was still present following the treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615058-2019-00005 |
| MDR Report Key | 8635439 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-05-23 |
| Date of Report | 2019-05-22 |
| Date of Event | 2019-04-23 |
| Date Mfgr Received | 2019-04-25 |
| Device Manufacturer Date | 2013-03-18 |
| Date Added to Maude | 2019-05-23 |
| 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 STREET |
| Manufacturer City | TIRAT CARMEL, 39120 |
| Manufacturer Country | IS |
| Manufacturer Postal | 39120 |
| Manufacturer G1 | INSIGHTEC |
| Manufacturer Street | 5 NACHUM HETH STREET |
| Manufacturer City | TIRAL CARMEL, 39120 |
| Manufacturer Country | IS |
| Manufacturer Postal Code | 39120 |
| 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 | 2019-05-23 |
| 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 | 2019-05-23 |