MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-09-27 for EXABLATE 2100 16111 manufactured by Insightec, Ltd..
[87508946]
Device has been evaluated and determined it works per its specifications and labeled indications. Treatment resulting in injury was in accordance with approved indications and the reported event is a known inherent risk of the procedure. Insightec internal reference (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[87508947]
During the uterine fibroid treatment, the exablate system detected heating between the patient's right abdominal wall and the gel pad coupling in sonications 51, 57, 61, 69 and 75. The physician stopped the treatment at sonication 75 and re-positioned the patient to finalize the treatment. The overheating on the patient skin reportedly resulted with a 2nd degree skin burn.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615058-2017-00003 |
| MDR Report Key | 6897487 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-09-27 |
| Date of Report | 2017-09-27 |
| Date of Event | 2017-06-14 |
| Date Facility Aware | 2017-06-14 |
| Date Mfgr Received | 2017-06-14 |
| Date Added to Maude | 2017-09-27 |
| 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 | MR. IDAN COHEN |
| Manufacturer Street | 5 NACHUM HETH STREET P.O. BOX 2039 |
| Manufacturer City | TIRAT CARMEL, ISRAEL 39120 |
| Manufacturer Country | IS |
| Manufacturer Postal | 39120 |
| Manufacturer G1 | INSIGHTEC, LTD |
| Manufacturer Street | 5 NACHUM HETH STREET P.O. BOX 2039 |
| Manufacturer City | TIRAT CARMEL, ISRAEL 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 2100 |
| Generic Name | MR GUIDED FOCUSED ULTRASOUND |
| Product Code | NRZ |
| Date Received | 2017-09-27 |
| Model Number | 2100 |
| Catalog Number | 16111 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INSIGHTEC, LTD. |
| Manufacturer Address | 5 NACHUM HETH STREET P.O. BOX 2039 TIRAT CARMEL, ISRAEL 31290 IS 31290 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-09-27 |