MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-08-18 for XKNIFE 5.0 INSTALL KIT XK5 manufactured by Integra, Burlington.
[2157184]
A (b)(4) software was described to have the following issues: there were two issues that occurred during the case but only one was responsible for the case being postponed. The two issues were: preplanned contours on the mri image set appeared shifted in the coronal and sagittal reconstructed image sets in the contouring mode. (contours were fine in the planning mode. ) they were able to work around this problem and continue with the case. The software would crash when they typed a value into a field and then hit the tab or enter key. After the software crashed a few times, it was decided to cancel the case.
Patient Sequence No: 1, Text Type: D, B5
[9396108]
The device involved in the reported incident is not expected to be received for evaluation. An investigation has been initiated based upon the reported info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1222895-2011-00013 |
| MDR Report Key | 2258230 |
| Report Source | 05 |
| Date Received | 2011-08-18 |
| Date of Report | 2011-08-18 |
| Date Mfgr Received | 2011-07-20 |
| Date Added to Maude | 2012-06-21 |
| 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 5.0 INSTALL KIT |
| Generic Name | NEURO |
| Product Code | KPQ |
| Date Received | 2011-08-18 |
| Catalog Number | XK5 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA, BURLINGTON |
| Manufacturer Address | BURLINGTON MA 01803 US 01803 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-08-18 |