MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2007-01-04 for EXABLATE 2000 * manufactured by Insightec, Ltd..
[597414]
Pt experienced full skin burn post treatment. The pt was a part of clinical study. This case was reported to the local ethic committee. The burn occurred in a previous laparoscopic scar area that was noted by the treating team only during the recovery phase of the treatment. The pt did not complain of pain. Follow up mr was performed, and the pt was referred to plastic surgeons.
Patient Sequence No: 1, Text Type: D, B5
[7915110]
In device labeling, it is clearly stated that in treatment planning, the operator should avoid scars. Possible tissue ablation caused by scars are anticipated adverse events. In this case, the scar was detected only after treatment, thus, there was no conscious violation of device labeling.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9615058-2005-00003 |
| MDR Report Key | 801662 |
| Report Source | 01,07 |
| Date Received | 2007-01-04 |
| Date of Report | 2006-08-15 |
| Date of Event | 2004-10-07 |
| Device Manufacturer Date | 2001-01-01 |
| Date Added to Maude | 2007-01-10 |
| 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, MANAGER |
| Manufacturer Street | 5 NACHUM HETH STREET P.O. BOX 2039 |
| Manufacturer City | TIRAT CARMEL 31290 |
| Manufacturer Country | IS |
| Manufacturer Postal | 31290 |
| Manufacturer Phone | 9724813131 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EXABLATE 2000 |
| Generic Name | FOCUSED ULTRASOUND |
| Product Code | MIK |
| Date Received | 2007-01-04 |
| Model Number | EXABLATE 2000 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 789185 |
| Manufacturer | INSIGHTEC, LTD. |
| Manufacturer Address | 5 NACHUM HETH ST. P.O. BOX 2059 TIRAT CARMEL IS 39120 |
| Baseline Brand Name | MK2 - EXABLATE |
| Baseline Generic Name | NA |
| Baseline Model No | EXABLATE 2000 |
| Baseline Catalog No | NA |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2007-01-04 |