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 2015-10-16 for LEKSELL GAMMA KNIFE PERFEXION manufactured by Elekta Instrument Ab.
[28513720]
The manufacturer's investigation determined that for released software versions (9. 1 to 11. 0), the system is sensitive to a single fault on the input electronics on ppc1 (microprocessor) for the continue button signal. This has potential safety implications during the clearance check pps movements. Please see the attached risk assessment ((b)(4)) for further details. If the failure occurs during clearance positioning, the effect is that the pps movement will not stop when the continue button is released, but instead will continue to its target position. In the unlikely case that the clearance tool arm is in a position where it could collide with the patient and the operator does not move the clearance tool arm away from the patient, a head injury could occur. The likelihood of this occurring is determined to be improbable, therefore no field corrective action on released versions of the software nor product documentation updates are needed.
Patient Sequence No: 1, Text Type: N, H10
[28513721]
There was no report of an adverse event. During the manufacturer's verification of an upcoming software release (version 11. 1), a software improvement was made to reduce the possibility for a single fault on the mechanical buttons or electronics to result in an unwanted patient positioning system (pps) movement during the clearance check. The manufacturer's internal investigation determined that the released software versions from 9. 1 to 11. 0 do not require an upgrade to incorporate the improvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612186-2015-00008 |
| MDR Report Key | 5156389 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2015-10-16 |
| Date of Report | 2015-10-16 |
| Date Mfgr Received | 2015-09-18 |
| Date Added to Maude | 2015-10-16 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| 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 PERFEXION |
| Generic Name | SYSTEM, RADIATION THERAPY, RADIONUCLIDE |
| Product Code | IWB |
| Date Received | 2015-10-16 |
| Lot Number | 9.1 - 11.0 |
| 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 | 2015-10-16 |