MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2015-01-23 for MRGFUS EXABLATE 2100 manufactured by Insightec Ltd..
[19496915]
Treatment flow was without exceptional events, although the pt stopped the treatment several times due to lower abdominal cramps. At the end of the treatment the pt was dismissed with mild cramps and bloating symptom. During the following two days (weekend) the patient had abdominal pain and on monday (3 days after the treatment) she was operated in another hospital for peritonitis. Laparotomy revealed a small bowel transmural perforation; with local signs of peritonitis. The area with the perforation was resected with primary anastomosis, and the abdominal cavity was irrigated. Post-surgery recovery of the pt was without any complications.
Patient Sequence No: 1, Text Type: D, B5
[19538789]
Device was reviewed to operating within its specifications. Reason of adverse event is user error. Insightec training material already explains and address such situations. Insightec findings were presented and discussed with the site.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9615058-2015-00001 |
| MDR Report Key | 4447821 |
| Report Source | 01,07 |
| Date Received | 2015-01-23 |
| Date of Report | 2015-01-15 |
| Date of Event | 2014-12-15 |
| Date Mfgr Received | 2015-01-11 |
| Date Added to Maude | 2015-01-23 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | ORI LUBIN, MANAGER |
| Manufacturer Street | 5 NAHUM HETH STREET P.O. BOX 2039 |
| Manufacturer City | TIRAT CARMEL 31290 |
| Manufacturer Country | IS |
| Manufacturer Postal | 31290 |
| Manufacturer Phone | 544881399 |
| 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 | 2015-01-23 |
| Model Number | 2100 |
| 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. Hospitalization; 2. Required No Informationntervention | 2015-01-23 |