MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2011-05-22 for MRGFUS EXABLATE 2100 manufactured by Insightec Ltd..
[2074660]
The pt: a (b)(6) yrs old, female, presenting with fibroid attributable menorrhagia and abdominal pain during the last year. Mri revealed an intramural posterior fibroid, volume of approx 50cc (41mm x 41mm x 53mm); hypo-intense on t2w imaging. Treatment was planned for a single session, but at the end of the first session the treating physicians found out that a significant portion of the fibroid remained perfused and decided complete the treatment in a second session on the following day (since the pt lives far from the hosp). Treatment sessions took place on (b)(6), 2011 and (b)(6), 2011. Both treatment sessions were described as uneventful. The pt was planned to stay at the hosp overnight (which is standard of care in (b)(6)). She was expected to be discharged on (b)(6). However, due to complaints about spastic abdominal pain, the pt remained another night for observation in the hosp. In the morning of (b)(6), the pt still complained about abdominal pain and her measured pulse was approx 105 bpm, and ct revealed air in the abdominal cavity suggesting bowel perforation. The pt underwent emergency laparotomy where a term...
Patient Sequence No: 1, Text Type: D, B5
[9199636]
Device has been diagnosed to work according to it's specifications. Reason of adverse event is user error. Treating physician failed to notice organs movement. Insightec training material already explains and address such situations thus we did not find any room for improvement of procedure. Site was re trained following this event. Please see full analysis report attached.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9615058-2011-00001 |
| MDR Report Key | 2147572 |
| Report Source | 01,07 |
| Date Received | 2011-05-22 |
| Date of Report | 2011-05-22 |
| Date of Event | 2011-05-14 |
| Date Mfgr Received | 2011-05-18 |
| Device Manufacturer Date | 2010-05-01 |
| Date Added to Maude | 2011-07-06 |
| 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 | 0 |
| Manufacturer Contact | ORI LUBIN, MGR. |
| Manufacturer Street | 5 NAHUM HETH ST. PO BOX 2039 |
| Manufacturer City | TIRAT CARMEL 31290 |
| Manufacturer Country | IS |
| Manufacturer Postal | 31290 |
| Manufacturer Phone | 544881399 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MRGFUS EXABLATE |
| Generic Name | FOCUSED ULTRASOUND |
| Product Code | NRZ |
| Date Received | 2011-05-22 |
| Model Number | 2100 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INSIGHTEC LTD. |
| Manufacturer Address | 5 NAHUM HET. TIRAT CARMEL 39120 IS 39120 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2011-05-22 |