MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-05-20 for XKNIFE RT LINUX WORKSTATION RTLXCOMP manufactured by Integra Radionics.
[1507419]
Xknife rt linux workstation; the outline of the 3 cm cone in the software appeared bigger than the 3. 5 cm cone. The incident was described as follows by the reporting physician; "during planning in the arc mode it was noted that the (circular) collimator outline of 30 mm diameter field is bigger than the 32. 5 mm field. I checked the dose distribution for both fields and they seem ok, but it looks strange and a little bit annoying for our neurosurgeon. For the 30 mm field this collimator outline is equal with about the 50% isodose line and are equal with about the 80% for the others. Interestingly we have this problem only for this field diameter. " the physician was asked if any pts were treated if any injury occurred. The physician stated that 4 males and 1 female were treated using this cone but none of them was injured because "we checked each case carefully the isodose curves and chose the diameter according to isodoses and not to the collimator outline. " additional clinical info has been requested.
Patient Sequence No: 1, Text Type: D, B5
[8626995]
The device involved in the reported incident has been received for eval. An investigation has been initiated based upon the reported info. Integra engineers completed a preliminary eval of this device and the following was determined; the preliminary investigation determined that the "diameter" parameter for the 30. 0 mm cone in the sites' beam data file had been incorrectly set to 37. 5 mm. Other parameters for the 30. 0 mm cone were found to be correct. Additional info has been requested to complete the investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1222895-2010-00004 |
| MDR Report Key | 1711126 |
| Report Source | 05 |
| Date Received | 2010-05-20 |
| Date of Report | 2010-05-20 |
| Date Mfgr Received | 2010-04-21 |
| Date Added to Maude | 2011-12-23 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | LINDA SERENTINO |
| Manufacturer Street | 315 ENTERPRISE DR |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099365560 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | XKNIFE RT LINUX WORKSTATION |
| Generic Name | NA |
| Product Code | KPQ |
| Date Received | 2010-05-20 |
| Catalog Number | RTLXCOMP |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA RADIONICS |
| Manufacturer Address | MA 01803 US 01803 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-05-20 |