MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2014-08-13 for MRGFUS EXABLATE 2000 manufactured by Insightec Ltd..
[4799152]
Pt underwent an uneventful mrgfus procedure on (b)(6) 2014, but experienced severe pain immediately after the procedure. She was readmitted at (b)(6) on the (b)(6) 2014 with pain and had an axr/cxr demonstrating fecal loading and no frank obstruction/perforation and a pelvic ultra sound demonstrating a moderate amount of free fluid/reactive but nil other abnormality. The pt was afebrile, normotensive, without tachycardia and had a soft abdomen with pain predominantly over her uterus. Crp was 5, initial wcc 13. 5 which 12/24 later was 5. 5. She was given aperients for constipation and emptied her bowels. She was discharged home on the (b)(6) feeling better. The pt subsequently presented 36 hours later with an acute abdomen to (b)(6), had evidence of a small bowel perforation at laparotomy and underwent a small bowel resection with abdominal cavity washout. As of (b)(6) the pt is recovering well.
Patient Sequence No: 1, Text Type: D, B5
[12345431]
Device has been diagnosed to work according to it's specs. Reason of adverse event is user error. Insightec training material already explains and address improvement of procedure. Site is going to be trained following this event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9615058-2014-00005 |
| MDR Report Key | 4028120 |
| Report Source | 01,07 |
| Date Received | 2014-08-13 |
| Date of Report | 2014-08-12 |
| Date of Event | 2014-07-18 |
| Date Mfgr Received | 2014-08-05 |
| Date Added to Maude | 2014-08-21 |
| 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, MGR |
| Manufacturer Street | 5 NAHUM ST. PO 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 | 2014-08-13 |
| 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 HET TIRAT CARMEL 39120 IS 39120 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2014-08-13 |