MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-01 for LEKSELL GAMMA KNIFE ICON 1016200 manufactured by Elekta Instrument Ab.
[42067000]
Investigation is ongoing.
Patient Sequence No: 1, Text Type: N, H10
[42067001]
It has been reported there may be an offset in stereotactic references - a possible 1. 6mm difference found in some icon images.
Patient Sequence No: 1, Text Type: D, B5
[51522065]
A root cause analysis was conducted involving extensive calibration and measurements. The investigation concludes that the shift is caused by a skewed g-frame caused by asymmetric and high tension in the g-frame attachment screws in combination with extended posts. Multiple use error must occur for the cause to happen. The use errors are deemed unusual since the correct g-frame training and usage is detailed in the ifu and the fiducial error is clearly displayed to the lgp user.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612186-2016-00004 |
| MDR Report Key | 5540856 |
| Date Received | 2016-04-01 |
| Date of Report | 2016-07-22 |
| Date of Event | 2016-03-14 |
| Date Mfgr Received | 2016-07-22 |
| Date Added to Maude | 2016-04-01 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | PMS |
| Manufacturer Street | LINAC HOUSE FLEMING WAY |
| Manufacturer City | CRAWLEY, WEST SUSSEX RH109RR |
| Manufacturer Country | UK |
| Manufacturer Postal | RH10 9RR |
| Manufacturer G1 | ELEKTA INSTRUMENT AB |
| Manufacturer Street | PO BOX 7593 |
| Manufacturer City | STOCKHOLM, SE10393 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | SE103 93 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEKSELL GAMMA KNIFE ICON |
| Generic Name | SYSTEM, RADIATION THERAPY, RADIONUCLIDE, PRODUCT CODE: IWB |
| Product Code | IWB |
| Date Received | 2016-04-01 |
| Model Number | 1016200 |
| 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 | PO BOX 7593 STOCKHOLM, SE10393 SW SE103 93 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-04-01 |