MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-02-26 for EXABLATE 4000 SYS940201 manufactured by Insightec Ltd.
[183080790]
The treatment review has not indicated any technical failures of the system. Treatment parameters were in line with typical range. The system performance was found to be according to spec and as expected. No new risk was recognized
Patient Sequence No: 1, Text Type: N, H10
[183080791]
At 6 months post essential tremor treatment, on follow up visit , the patient complained of affected taste. The assumption is that the taste issue might be following the treatment and may potentially lead to permanent damage.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615058-2020-00002 |
| MDR Report Key | 9754452 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-02-26 |
| Date of Report | 2020-02-26 |
| Date of Event | 2019-06-06 |
| Date Mfgr Received | 2020-01-27 |
| Device Manufacturer Date | 2016-09-06 |
| Date Added to Maude | 2020-02-26 |
| 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 LTD |
| Manufacturer Street | 5 NACHUM HETH |
| Manufacturer City | TIRAT 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 | 2020-02-26 |
| Model Number | 4000 |
| Catalog Number | SYS940201 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INSIGHTEC LTD |
| Manufacturer Address | 5 NACHUM HETH STREET TIRAT CARMEL, 39120 IS 39120 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2020-02-26 |