MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2014-06-04 for MRGFUS EXABLATE 2100 manufactured by Insightec Ltd..
[4567710]
In compliance with regulatory requirements such as those in europe, insightec initiated a post marketing surveillance questionnaire to capture customers feedback. One of our customers, dr. (b)(6), cited in their feedback that one of this patients reported a bowel perforation. They also added that their patient suffered with chronic inflammatory disease of the bowel. Patient was treated for their uterine fibroids with the exablate device. For legal reason, we could not get any additional data from the site. However, we have reviewed last year service calls, device maintenance files and actions and found no issues that could suggest device has not been working according to its original specifications and or that device experienced deterioration. Hence, at this time, we are unable to make a full review of the event.
Patient Sequence No: 1, Text Type: D, B5
[12019192]
For legal reasons, the customer was not able to provide additional detail, when requested by insightec. Due to the lack of additional information from the customer, insightec cannot conclude whether or not the device could have caused or contributed to this injury. In an abundance of caution, the company is submitting this mdr report based solely on the initial limited information provided to the company. It should be noted that the review of the device history did not show any malfunction nor deviation from the device normal operating specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9615058-2014-00003 |
| MDR Report Key | 3876312 |
| Report Source | 01,07 |
| Date Received | 2014-06-04 |
| Date of Report | 2014-05-25 |
| Date of Event | 2014-05-25 |
| Date Mfgr Received | 2011-05-16 |
| Device Manufacturer Date | 2010-11-01 |
| Date Added to Maude | 2014-06-18 |
| 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 312290 |
| Manufacturer Country | IS |
| Manufacturer Postal | 312290 |
| Manufacturer Phone | 54488199 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MRGFUS EXABLATE |
| Generic Name | HIFU |
| Product Code | NRZ |
| Date Received | 2014-06-04 |
| 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 ST. TIRAT CARMEL 39120 IS 39120 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2014-06-04 |