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 2016-01-05 for LEKSELL GAMMA KNIFE ICON manufactured by Elekta Instrument Ab.
[35081143]
The manufacturer's investigation concluded that there was the potential for an incorrect reference position to be measured during a cbct scan. The hdmm patient displacement uses the reference position when monitoring the patient movement in the dose control function. The reason for this is that the reference patient position during a scan is also calculated after the scan is finished as long as the start/enable buttons are active. If the patient moves during this time interval between the last cbct projection and release of the start/enable buttons, the patient position reference will be affected in an incorrect way; the patient position reference should only be measured while cbct projections are being taken. This could later during treatment hide a patient position shift and delay the dose control function shutting off the radiation. Investigation and root cause analysis: the system relies on the relative measurements between a reference point and the current position of the patient marker. This distance is called the patient displacement. The displacement is used to present a graph to the user and as a criteria for the ifmm (intra-fraction motion management) alarm. The reference point is crucial to ifmm. The reference point is defined as the average position of the patient marker during a cbct scan. The principle is that the patient position shown in the cbct image shall be captured as the reference point for the patient displacement calculation. The problem investigated here is that the reference point is calculated, using patient position also after the cbct scan is finished until the start/enable buttons are released. Risk assessment: the risk of an incorrect reference point being calculated depends on the following: 1. The patient moves after last projection is finished but before the start/enable is released. 2. The movement of the patient is not larger than 4 mm, otherwise a warning is shown. The worst case effect is treatment in the wrong position, however for the issue to occur, a combination of patient movement during a small time frame and the start/enable not being released after the scan has finished, together with the warning if the patient movement is too big was determined to be improbable. The problem has been fixed in software version 11. 1, which has not been released to date. A field safety corrective action is not required to update the software or product documentation for the released versions as there was no new risk identified. At the time of this report, there were no installations of the leksell gamma knife icon in the us.
Patient Sequence No: 1, Text Type: N, H10
[35081144]
During the manufacturer's testing of an upcoming software release (version 11. 1) for the leksell gamma knife icon, it was found that the high definition motion management (hdmm) patient displacement indication could be incorrectly affected by patient movement after the cone beam computed tomography (cbct) x-ray has finished, prior to the start/enable buttons being released. This issue affects all released versions of the icon control system software (versions 11. 0 onwards), however, the manufacturer is not aware of any adverse events.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612186-2016-00001 |
| MDR Report Key | 5344588 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-01-05 |
| Date of Report | 2016-01-05 |
| Date Mfgr Received | 2015-12-09 |
| Date Added to Maude | 2016-01-05 |
| 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 | 2016-01-05 |
| 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 | 2016-01-05 |