MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,05,06 report with the FDA on 2010-09-27 for LEKSELL GAMMA KNIFE PERFEXION WITH EXTEND FRAME SYSTEM 1009622 manufactured by Elekta Instrument Ab.
[20744371]
During setup of pt at ct, it was difficult to achieve good results at rct measurement. The rod turned out to have loosened from the mouthpiece. All mouthpieces at customers were then checked by hand force prior to the next setup trial. After ct prior to treatment, the same thing happened again. Size of the mouthpiece was xl p2.
Patient Sequence No: 1, Text Type: D, B5
[20823158]
Investigation results: a failure of an extend mouthpiece was found during a pt setup. The anterior fixation bar of the frontpiece came loose from the dental impression tray. The joint between the anterior fixation bar and the dental impression tray is glued using cyanoacrylate glue. The bond gap has been too large in some mouthpieces, resulting in a too small contact surface between the two parts and as a consequence a too weak joint. The result is that the glue line can break when the mouthpiece is twisted, which leads to either a play between the anterior fixation bar and the dental impression tray, or that the dental impression tray comes loose. It is not possible to determine if the glue lines on a mouthpiece are bad, neither by visual inspection nor by pulling or bending the extend mouthpiece. Corrective action: elekta instruments (b)(4) issued an important notice a342 "potential failure of the extend mouthpiece" to affected users instructing them to return the old mouthpieces to elekta instruments (b)(4) which will be replaced with new mouthpieces. The corrective actions have been identified within the (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612186-2010-00005 |
| MDR Report Key | 1851032 |
| Report Source | 00,01,05,06 |
| Date Received | 2010-09-27 |
| Date of Report | 2010-09-24 |
| Date of Event | 2010-09-16 |
| Date Mfgr Received | 2010-09-17 |
| Date Added to Maude | 2012-01-09 |
| 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 |
| Removal Correction Number | 9612186-092710-016-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEKSELL GAMMA KNIFE PERFEXION WITH EXTEND FRAME SYSTEM |
| Generic Name | SYSTEM, RADIATION THERAPY, RADIONUCLIDE |
| Product Code | IWB |
| Date Received | 2010-09-27 |
| Catalog Number | 1009622 |
| 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 | 2010-09-27 |