MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-05-31 for EXABLATE 2000 manufactured by Insightec, Ltd..
[15209637]
Stop sonication on console failed to operate. In this event the physician used the stop sonication button to literally stop the sonication and not as an emergency button. The executed sonication was safe thus absolutely no harm to patient.
Patient Sequence No: 1, Text Type: D, B5
[15719375]
The stop sonication assembly has been available in its current form almost from the beginning of the use of the exablate and this is the first time in probably around 5000 treatments that such a defect has been reported. Although in this case no adverse event happened, since this is an emergency safety feature, its failure is unacceptable. Company sent an application note to all sites. The note requires the users to press the stop sonication button during power-up for the daily quality assurance (dqa) testing. This action should only take a few seconds and should completely prevent the malfunction from happening during treatment since company cannot envisage any scenario where the stop button fails spontaneously during treatment.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9615058-2009-00002 |
| MDR Report Key | 2291655 |
| Report Source | 07 |
| Date Received | 2011-05-31 |
| Date of Report | 2009-12-14 |
| Date of Event | 2009-11-20 |
| Date Mfgr Received | 2009-11-24 |
| Date Added to Maude | 2012-04-11 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | ORI LUBIN, MANAGER |
| Manufacturer Street | 5 NAHUM HETH ST. P.O. BOX 2039 |
| Manufacturer City | TIRAT CARMEL 31290 |
| Manufacturer Country | IS |
| Manufacturer Postal | 31290 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EXABLATE 2000 |
| Generic Name | MRGFUS |
| Product Code | NRZ |
| Date Received | 2011-05-31 |
| Model Number | EXABLATE 2000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INSIGHTEC, LTD. |
| Manufacturer Address | 5 NACHUMHETH STREET |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-05-31 |