MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2007-02-26 for EXABLATE 2000 * manufactured by Insightec, Ltd..
[21990270]
During the sonications, inadequate use of fiducials (markers) led to the physician not noticing a superior movement of the pt and inferior movement of the intenstine into the treatment field. This movement then led to a number of sonications that on the original planning images had looked safe, but in reality led the passzone through the intenstine. This was clearly visible on pre-sonication images that showed the passage of the beam through the intenstine - but was also disregarded by the treating physician. Sonication through intestine can cause perforation of the intestine wall. The pt underwent surgery for intestine repair. She has been released from hosp and is currently reported to be doing well.
Patient Sequence No: 1, Text Type: N, H10
[22174738]
Pt was diagnosed with 'poured fibrous purulent peritonitis. ' insightec has no add'l data about the pt's care post this diagnosis in spite of several attempts. There is no collaboration from the hosp in this matter. There is no data regarding 'pt info'.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615058-2007-00002 |
| MDR Report Key | 822493 |
| Report Source | 01,07 |
| Date Received | 2007-02-26 |
| Date of Report | 2007-02-25 |
| Date of Event | 2007-01-19 |
| Device Manufacturer Date | 2005-06-01 |
| Date Added to Maude | 2007-03-05 |
| 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 | 9724813162 |
| 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 | MRGFUS |
| Product Code | MIK |
| Date Received | 2007-02-26 |
| Model Number | EXABLATE 2000 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 809897 |
| Manufacturer | INSIGHTEC, LTD. |
| Manufacturer Address | 5 NACHUM HETH ST PO 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 | 2007-02-26 |