MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05,06 report with the FDA on 2014-06-02 for LEKSELL GAMMA KNIFE PERFEXION manufactured by Elekta Instrument Ab.
[16010128]
The customer has reported that they are concerned that the frame adaptor is able to be placed on the qa tool when the locking clamps are in the incorrect position. There is about 1-2mm of play. This was picked up during morning qa focus check when the results came back failing.
Patient Sequence No: 1, Text Type: D, B5
[16312123]
The manufacturer's investigation is currently on-going. Further information will be provided when the investigation has been completed.
Patient Sequence No: 1, Text Type: N, H10
[36882057]
The leksell gamma knife perfexion coordinate frame is fixed to the patient positioning system before treatment using a frame adapter. The coordinate frame is locked to the frame adapter via latches. The latches are turned ninety degrees and then locked. The manufacturer's investigation have shown that it may be possible to have a situation where the adapter latches can get stuck just above the coordinate frame surface and as a result the coordinate frame will not be fixed properly. This could then result in a small play between the coordinate frame and the frame adapter in the leksell z-direction. A small "shelf" can be created if the latch has been forced into position when at a small angle. If the latch locks to that shelf there will be a play between the frame and the latch, which could possibly move the target from planned position by up to 0. 5 mm. The root cause is that frame adapters have not been manufactured according to specification. A field safety corrective notice (100-01-202-027) will be released to customers.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612186-2014-00003 |
| MDR Report Key | 3842894 |
| Report Source | 00,05,06 |
| Date Received | 2014-06-02 |
| Date of Report | 2014-10-08 |
| Date Mfgr Received | 2014-05-06 |
| Date Added to Maude | 2014-07-02 |
| 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 |
| Reporter Occupation | PHYSICIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | LINAC HOUSE FLEMING WAY |
| Manufacturer City | CRAWLEY, WEST SUSSEX RH109RR |
| Manufacturer Country | UK |
| Manufacturer Postal | RH10 9RR |
| Single Use | 3 |
| Remedial Action | RC |
| 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 | 2014-06-02 |
| Operator | PHYSICIST |
| 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 | P.O. BOX 7593 STOCKHOLM, 103-93 SW 103-93 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-06-02 |