MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07,08 report with the FDA on 2011-12-06 for XKNIFE 5.0 INSTALL KIT XK5 manufactured by Integra Burlington, Ma, Inc.
[2505834]
It was reported that the hospital was upgraded from the xknife rt4 to xknife v5. 0. 1 by an integra employee on (b)(6) 2011. It was reported that just before treating the pt on (b)(6) 2011 for a stereotactic radiosurgery (srs). The customer noticed the error on the couch angle. The couch angle number was incorrect on the beam setup sheets. The printout on the rt4 was 30 degree, but the x5. 01 was 330 degree. Thirty (30 degree on the rt4 was correct. The problem was corrected and the treatment was continued by reading the couch angle correctly. The distributor called integra technical support and during troubleshooting. It was discovered that the hospital/site's software was using the same data and not the site's specific data (example beamdata and configuration). The integra employee did not see this problem while he was on site at the hospital. The configuration file has been updated on (b)(6) 2011 by a technician from the distributor with instructions provided by integra technical support. The site's data is now being used by the customer. No pt injury was reported. Add'l clinical info has been requested.
Patient Sequence No: 1, Text Type: D, B5
[9577637]
The device involved in the reported incident is not expected to be received for eval. An investigation has been initiated based upon the reported info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1222895-2011-00037 |
| MDR Report Key | 2373742 |
| Report Source | 01,07,08 |
| Date Received | 2011-12-06 |
| Date of Report | 2011-12-06 |
| Date of Event | 2011-11-15 |
| Date Mfgr Received | 2011-11-15 |
| Date Added to Maude | 2012-07-20 |
| 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 | ROWENA SALVADOR |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | BLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099365581 |
| 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 | 2011-12-06 |
| Catalog Number | XK5 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2011-12-06 |