MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2015-11-04 for LEKSELL GAMMA KNIFE ICON manufactured by Elekta Instrument Ab.
[30384005]
To prevent incorrect calibration of the lgk system due to corrupt calibrationsettings. Txt file, a checksum (crc) mechanism has been implemented. Trying to use this incorrect file will therefore result in an error "error reading cbct calibration settings", described in the service tool log file and further use of the system is prevented. However, along with the reason for the failure (checksum mismatch), the correct expected checksum is presented. The likelihood for this issue to create a hazardous situation has been determined to be improbable, as this requires a multitude of unlikely events and use errors. However, should the issue occur, the worst case effect would be treatment of the patient in the wrong position. Due to the low probability of the issue occurring, the manufacturer concluded that software versions 11. 0 onwards do not require an upgrade nor an update to product documentation.
Patient Sequence No: 1, Text Type: N, H10
[30384006]
There was no report of an adverse event. During the manufacturer's testing of an upcoming software release (version 11. 1), a software vulnerability was found with verification (checksum) of the calibration settings and is also applicable to released version 11. 0.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612186-2015-00009 |
| MDR Report Key | 5200997 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2015-11-04 |
| Date of Report | 2015-11-04 |
| Date Mfgr Received | 2015-10-09 |
| Date Added to Maude | 2015-11-04 |
| 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 | GPMS |
| 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 |
| Date Received | 2015-11-04 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2015-11-04 |