MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2009-07-20 for LEKSELL GAMMA KNIFE PERFEXION 6056 manufactured by Elekta Instrument Ab.
[1257803]
The customer reported having problems with the clamp for the headframe. They stated that they are not always able to get the first clamp to close all the way at times.
Patient Sequence No: 1, Text Type: D, B5
[8408352]
Investigation results: investigation into this issue has shown that it may be possible to have a situation where the frame adaptor latches can get stuck just above the frame surface and, as a result, the frame will not be fixed properly. This could then result in a small amount of movement between the stereotactic frame and the frame adaptor in the leksell "z" direction. This "shelf" can be created if the latch has been forced into a locked position when at a small angle. Because this can result in possible movement between the stereotactic frame and the frame adaptor, there is the potential that this could cause the patient to be positioned incorrectly during treatment. Release of an important notice is planned to give customers a clear instruction on how to ensure that the frame is latched correctly, which will be filed appropriately with the fda as an 806 correction report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612186-2009-00012 |
| MDR Report Key | 1464508 |
| Report Source | 05,06 |
| Date Received | 2009-07-20 |
| Date of Report | 2009-07-20 |
| Date of Event | 2009-06-22 |
| Date Mfgr Received | 2009-06-30 |
| Date Added to Maude | 2010-02-02 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer City | STOCKHOLM |
| Manufacturer Country | SW |
| Manufacturer Phone | 293654250 |
| Single Use | 3 |
| Remedial Action | NO |
| 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 | 2009-07-20 |
| Model Number | 6056 |
| Operator | HEALTH PROFESSIONAL |
| 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 | STOCKHOLM SW |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-07-20 |