MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-11-09 for LEKSELL GAMMA KNIFE ICON 1016200 manufactured by Elekta Instrument Ab.
[60024284]
Investigation is not complete.
Patient Sequence No: 1, Text Type: N, H10
[60024325]
In internal testing, it was found that in certain circumstances, data that has already become corrupt in the database (due to hardware failure or some other unexpected event), could pass through the upgrade procedure without notifying the service engineer upgrading the system. In this case, the data will be treated as non-corrupt after the upgrade and if an error existed before the upgrade, this error will be unnoticed and could later cause an incorrect treatment. For the specific circumstances to take place, at least two independent data errors must have occured in the database, and during upgrade the service user will be notified about one of them. If no data corruption was reported during the upgrade, this error cannot have occured. The initial analysis shows that this problem might occur when upgrading dfm 2. 0 (lgk icon) and not on any older versions of the gammaknife/software.
Patient Sequence No: 1, Text Type: D, B5
[65847204]
The problem is caused by an erroneous implementation in 'tpidbdump' application run on the target workstation prior to upgrading the system. This application will read all treatments from the database and save them to files. If at least two independent data errors exist in the database, where one error is in the fraction part of the database and the other is in the treatment part of the database, treatments with data errors in the treatment part will be saved to files as if there are no data error in that treatment. After upgrading the system, the application 'tpidbrestore' is run to restore the treatments into the database. The checksums in the upgraded data are recalculated, possibly hiding erroneous treatment data. There is no indication that these type of data errors has occurred. The probability for these type of errors to occur is very low and is not increased by this problem. However, as a precaution, it is recommended to take special action in this case by discarding any pending treatments. During installation. The manufacturer is reviewing an update to the installation instruction used by service personnel, thereby the risk of continued treatment with corrupted treatment data is eliminated. The remaining risk after this mitigation is that historical treatment data (already performed treatments) might be incorrect, affecting functionality in lgp that is used when planning new treatments for the same patient. If no data corruption is detected during upgrade, the system works as intended and no action is needed. The service instruction update is applicable upon upgrade to lgp versions 10. 1. X, 10. 2. X, 11. 0. X. , and 11. 1. When upgrading from lgp version 11. 1 the problem is resolved in the product (checksum mechanism corrected).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612186-2016-00009 |
| MDR Report Key | 6089076 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-11-09 |
| Date of Report | 2017-01-20 |
| Date of Event | 2016-10-12 |
| Date Mfgr Received | 2016-10-12 |
| Date Added to Maude | 2016-11-09 |
| 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 | KUNGSTENSGATAN 18 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 | 2016-11-09 |
| Model Number | 1016200 |
| 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 | KUNGSTENSGATAN 18 PO BOX 7593 STOCKHOLM, SE10393 SW SE103 93 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-11-09 |