MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,07 report with the FDA on 2012-11-16 for XKNIFE 5.0 INSTALL KIT XK5 manufactured by Integra Burlington, Ma, Inc..
[3042831]
"x1 and y1 jaws showing as -3. 5 in (b)(4), should be +3. 5 due to software error. " the error message occurs in the (b)(4) system. The (b)(4)system is third party software integrated with the linac that verifies the proper position of the couch, collimator, gantry and any beam modifiers before treatment is delivered. Xknife is a radiosurgery and radiotherapy treatment planning system intended for use in stereotactic and non-stereotactic (frameless stereotactic), collimated beam, computer planned, linear accelerator (linac) based treatment. The software installation is conducted prior to scheduling the use of the system to treat patients. Therefore, there was no patient contact.
Patient Sequence No: 1, Text Type: D, B5
[10296117]
To date, the device involved in the reported incident has not been received for evaluation. An investigation has been initiated based upon the reported information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1222895-2012-00046 |
| MDR Report Key | 2845285 |
| Report Source | 00,07 |
| Date Received | 2012-11-16 |
| Date of Report | 2012-11-16 |
| Date Mfgr Received | 2012-08-24 |
| Date Added to Maude | 2013-02-25 |
| 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 | LINDA SERENTINO |
| Manufacturer Street | 315 ENTERPRISE DR. |
| Manufacturer Phone | 6099365560 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | XKNIFE 5.0 INSTALL KIT |
| Generic Name | NEURO |
| Product Code | KPQ |
| Date Received | 2012-11-16 |
| Catalog Number | XK5 |
| Lot Number | 5.0.1 |
| Operator | OTHER |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA BURLINGTON, MA, INC. |
| Manufacturer Address | BURLINGTON MA 01803 US 01803 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-11-16 |