MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2007-08-27 for EXABLATE 2000 manufactured by Insightec, Ltd..
[16030046]
During treatment, after sonication 81 was stopped and the mr performed a new prescan, the thermal spot in sonication 82 appeared to be 8 mm inferior to its predicted location. This was repeated also in sonication 83. After the operator forced a new prescan and in the next sonication, the location of the spot was back to where it should be.
Patient Sequence No: 1, Text Type: D, B5
[16157125]
Mr frequency shift temporarily impacted image display in a way that could have been misleading. The exablate 2000 performs according to it's specifications. The mr frequency shift provided misleading data to the exablate 2000. No patient injury occurred. If the observed event were to recur, the likelihood of serious injury or death is mitigated by device labeling. Out of an abundance of caution, the company has elected to report the event. The company will introduce a minor software change that will notify the user not to adjust when the central mr frequency has changed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9615058-2007-00006 |
| MDR Report Key | 906999 |
| Report Source | 01,07 |
| Date Received | 2007-08-27 |
| Date of Report | 2007-08-27 |
| Date of Event | 2007-04-24 |
| Date Mfgr Received | 2006-04-30 |
| Date Added to Maude | 2007-09-24 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | ORI LUBIN, MANAGER |
| Manufacturer Street | 5 NACHUM STREET P.O. BOX 2039 |
| Manufacturer City | TIRAT CARMEL 31290 |
| Manufacturer Country | IS |
| Manufacturer Postal | 31290 |
| Manufacturer Phone | 9724813162 |
| Single Use | 3 |
| Remedial Action | MA |
| 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 | 2007-08-27 |
| Model Number | EXABLATE 2000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 889016 |
| Manufacturer | INSIGHTEC, LTD. |
| Manufacturer Address | 5 NACHUM HETH STREET P.O. BOX 2059 TIRAT CARMEL IS 39120 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-08-27 |