MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05,06 report with the FDA on 2010-09-02 for LEKSELL GAMMA KNIFE ARC 904121 manufactured by Elekta Instrument Ab.
[1588243]
Leksell stereotactic neurology system was installed in 2008, (b)(6). From the beginning, the accuracy was not correct according to the (b)(6) target coordinates. By experience, the system shows 1, 5 mm wrong in x and 0,5-0,7 mm in y. The doctor manually adjusts the coordinates accordingly and then comes to correct position for implantation of dbs electrode - this is confirmed by post operative mr-images. No mistreatment but potential for mistreatment due to the incorrect settings.
Patient Sequence No: 1, Text Type: D, B5
[8757585]
The customer will upgrade to counter-scale to increase accuracy of the system.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612186-2010-00004 |
| MDR Report Key | 1828219 |
| Report Source | 00,05,06 |
| Date Received | 2010-09-02 |
| Date of Report | 2001-08-27 |
| Date of Event | 2010-08-09 |
| Date Mfgr Received | 2010-01-03 |
| Date Added to Maude | 2010-09-10 |
| 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 City | STOCKHOLM |
| Manufacturer Country | SW |
| Manufacturer Phone | 293654250 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEKSELL GAMMA KNIFE |
| Generic Name | RADIATION THERAPY |
| Product Code | IWB |
| Date Received | 2010-09-02 |
| Catalog Number | ARC 904121 |
| Lot Number | GFD2085 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ELEKTA INSTRUMENT AB |
| Manufacturer Address | STOCKHOLM SW |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-09-02 |