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 2019-04-24 for EXABALTE 2100 SYS900002 manufactured by Insightec Ltd.
[142878355]
On (b)(6) 2018 insightec were notified by our insightec representative, insightec commercial development& international director, that during a conversation with the site ((b)(6)) chairman mr. (b)(6) mentioned, that a patient underwent exablate treatment for their uterine fibroids that resulted in bowel perforation. No additional data was given at this time. Despite insightec attempts to get the site to provide more information on this case, all attempts resulted in no communication the site. At this time, there is no additional information.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615058-2018-00007 |
| MDR Report Key | 8543600 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-04-24 |
| Date of Report | 2018-10-16 |
| Date Mfgr Received | 2018-02-13 |
| Device Manufacturer Date | 2011-11-30 |
| Date Added to Maude | 2019-04-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 |
| Manufacturer City | TIRAT CARMEL, 31290 |
| Manufacturer Country | IS |
| Manufacturer Postal | 31290 |
| Manufacturer G1 | INSIGHTEC LTD |
| Manufacturer Street | 5 NACHUM HETH STREET |
| Manufacturer City | TIRAT CARMEL, 31290 |
| Manufacturer Country | IS |
| Manufacturer Postal Code | 31290 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EXABALTE 2100 |
| Generic Name | MR GUIDED FOCUSED ULTRASOUND SYSTEM |
| Product Code | POH |
| Date Received | 2019-04-24 |
| Model Number | 2100 |
| Catalog Number | SYS900002 |
| 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 TIRAT CARMEL, 31290 IS 31290 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2019-04-24 |