MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-08-19 for LESKELL GAMMAKNIFE MODEL C/B-2 * manufactured by Elekta, Ab.
[1262687]
Two patients were scheduled for treatment using a leksell gammaknife model c/b-2 stereotactic radiosurgery unit, which uses an automatic positioning system (aps) to automatically change patient position during treatment. The unit is 11 years old but was upgraded in 2005. It appears that an error code came up which was cleared but left the machine out of sync with the second patient's exact position. It appears for this second patient all subsequent treatment points were offset by 4. 5 mm in the x-axis. Further evaluation reveals that gammaknife radiation treatment may not have been administered to the exact intended area for the second patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1460470 |
| MDR Report Key | 1460470 |
| Date Received | 2009-08-19 |
| Date of Report | 2009-08-17 |
| Date of Event | 2009-08-05 |
| Report Date | 2009-08-17 |
| Date Reported to FDA | 2009-08-19 |
| Date Added to Maude | 2009-09-02 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LESKELL GAMMAKNIFE MODEL C/B-2 |
| Generic Name | STEREOTACTIC RADIOSURGERY UNIT |
| Product Code | IWB |
| Date Received | 2009-08-19 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Age | 11 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ELEKTA, AB |
| Manufacturer Address | 475 PEACHTREE INDUSTRIAL BOULE NORCROSS GA 30092 US 30092 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-08-19 |