MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2014-09-24 for MRGFUS EXABLATE 2000 manufactured by Insightec, Ltd..
[4766747]
A (b)(6) year old woman with adenomyosis and menometrorrhagia was "commercially" treated on (b)(6) with no remarkable events. In hr pas the patient underwent myomectomy by laparotomy and several ivf attempts. Three days post-treatment ((b)(6) 2014) the patient complaint of abdominal pain and was referred to the emergency room. She arrived to the er on (b)(6) 2014. Following deterioration of her condition, she was taken to emergency for a laparotomy. It was reported indirectly to insightec that at laparotomy feces was found in the abdominal cavity but no apparent perforation of perforation site was detected. The patient dies on (b)(6) 2014. On (b)(6) pm was performed. At this time, the pm results are not available, per hospital management decision. No other information is available at this time as well.
Patient Sequence No: 1, Text Type: D, B5
[12246258]
Device has been diagnosed and found with no malfunctions. Site did not allow treatment review yet.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9615058-2014-00006 |
| MDR Report Key | 4146933 |
| Report Source | 01,07 |
| Date Received | 2014-09-24 |
| Date of Report | 2014-09-17 |
| Date of Event | 2014-09-17 |
| Date Mfgr Received | 2011-05-16 |
| Device Manufacturer Date | 2009-08-01 |
| Date Added to Maude | 2014-10-08 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | ORI LUBIN, MANAGER |
| Manufacturer Street | 5 NAHUM ST. PO BOX 2039 |
| Manufacturer City | TIRAT CARMEL 31290 |
| Manufacturer Country | IS |
| Manufacturer Postal | 31290 |
| Manufacturer Phone | 54488199 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MRGFUS EXABLATE |
| Generic Name | HIFU |
| Product Code | NRZ |
| Date Received | 2014-09-24 |
| Model Number | 2000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INSIGHTEC, LTD. |
| Manufacturer Address | 5 NAHUM ST. TIRAT CARMEL 3912001 IS 3912001 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2014-09-24 |