MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2016-10-13 for LEKSELL GAMMA KNIFE PERFEXION 715000 manufactured by Elekta Instrument Ab.
[57623543]
Investigation will continue when the returned part has been received.
Patient Sequence No: 1, Text Type: N, H10
[57623544]
One pin on the frame adapter broken off. During icon upgrade it was discovered that one of the pins securing the g-frame in the frame adapter had broken off. During the first set of films taken it was discovered that the position was off specification. The measurements form centre and off-centre positions for x-direction show very bad results that are outside our specifications (around 0. 54mm) from the center films (100, 100, 100)mm, and 0l8mm) from the off-center films (40, 160, 100) mm. In addition, the results from the y-direction for the center position are also bad (around 0. 36mm) and these are outside specification.
Patient Sequence No: 1, Text Type: D, B5
[65939016]
"other serious (important medical events)" was checked in error this has now been corrected. Added model number, returned to manufacturer checked yes box, updated - checked health professional and user facility, added date received by manufacturer, amended 510k number, added - labeled for single use = no, added - usage of device. Investigation results updated: investigation results: it was reported that the frame adapter pin (1006115) for guiding the g-frame was broken off on the frame adapter. The pins in the frame adapter are used to guide the g-frame to its position. If a pin falls off, or gets broken (as in this case) the dose might in the worst case miss the target with approximately 0,6-1,0 mm. This pin design was released in 2007 and the design of the pin has not been changed. This pin design has been used on many treatments and this issue has not been reported before to elekta. The position where the breaks occurred has a significant tension concentration factor in the bottom of the threads. However normal loads on the pin is low. Break is expected to have been momentary for reasons described below. The bending force for break a pin is significant high as the pin itself is very short. A large excessive load must have been applied to the pin itself. When examining the frame adapter, further damage was found on the frame adapters guide pin. The frame adapter guide pin is the pin that align the frame adapter to the pps fixation bracket. It looks like the frame adapter has been twisted out of position when partly fixated. This other damage shows that excessive force have been used when docking/undocking the frame adapter. Root cause: the frame adapter and the pin has been exposed to excessive force. The user has ignored the warnings that the frame adapter should be handled with care. The user has ignored the warnings to check if parts are missing or damaged. Conclusion: the user has not followed the user instructions and used excessive force to undock the frame adapter, therefore due to this misuse the pin has broken.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612186-2016-00008 |
| MDR Report Key | 6025504 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-10-13 |
| Date of Report | 2017-01-20 |
| Date of Event | 2016-09-15 |
| Date Mfgr Received | 2016-09-19 |
| Date Added to Maude | 2016-10-13 |
| 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 | SERVICE PERSONNEL |
| 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 PERFEXION |
| Generic Name | SYSTEM, RADIATION THERAPY, RADIONUCLIDE |
| Product Code | IWB |
| Date Received | 2016-10-13 |
| Model Number | 715000 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| 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 | 2016-10-13 |