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 2014-05-16 for LEKSELL GAMMA KNIFE PERFEXION manufactured by Elekta Instrument Ab.
[4404193]
There has been no adverse event. The customer has reported that the bearings in sector 3 are squeaking after implementation of fco 202 025. There is no access to the parts considering the presence of cobalt 60 sources.
Patient Sequence No: 1, Text Type: D, B5
[11892764]
The manufacturer's investigation is currently on-going and further information will be provided when the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[25006940]
The leksell gamma knife? Perfexion has a redundant positioning and measuring system consisting of both an absolute optical linear scale and a relative rotary encoder for each axis and sector. During system initialization both of these measurement systems are verified to match stored values for certain predefined physical positions. Any difference beyond the set tolerance (c:a 50um) will result in an error message and a system that is unusable for treatment. During treatment the motor servos use the rotary encoder values to monitor and drive the motors while the linear scales are used by the elekta control unit (ecu) to verify the acceleration, speed and position. Any difference beyond the defined values will terminate the treatment and return the system to a safe state by bypassing all normal servos and software, using the "safety system". In addition there is redundant software in the control system software that continuously verifies the health and responsiveness of the sub components to ensure that any problem is detected immediately and the safety system invoked. If one, several or all sectors seize due to a mechanical failure the system will detect this immediately and begin emergency exit of the patent from the radiation unit (ru) and close the shielding doors. It is known that normal wear and tear will cause the sectors to vibrate and cause noise during movement, this is not considered a hazard. Should the sectors seize up, e. G. In "beam-on" position, the control system will detect this and return the patient to a safe state.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612186-2014-00002 |
| MDR Report Key | 3814743 |
| Report Source | 00,05,06 |
| Date Received | 2014-05-16 |
| Date of Report | 2014-07-09 |
| Date of Event | 2014-05-16 |
| Date Mfgr Received | 2014-04-17 |
| Date Added to Maude | 2014-06-26 |
| 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 | 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 |
| 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 | 2014-05-16 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ELEKTA INSTRUMENT AB |
| Manufacturer Address | P.O. BOX 7593 STOCKHOLM, 103-93 MC 103-93 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-05-16 |