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 2010-10-12 for LEKSELL GAMMA KNIFE PERFEXION WITH EXTEND FRAME SYSTEM 1009622 manufactured by Elekta Instrument Ab.
[1771438]
While preparing a mouthpiece for dental impression, it was noted that the mouthpiece was broken. When inspecting other mouthpieces, five were noted to be broken. Mouthpieces to be replaced at no charge.
Patient Sequence No: 1, Text Type: D, B5
[8892828]
Corrective action: elekta instruments ab issued an important notice (b)(4) "potential failure of the extend mouthpiece" to affected users instructing them the return the old mouthpieces to elekta instruments ab which will be replaced with new mouthpieces. The corrective actions have been identified within the important notice (b)(4) and fco (b)(4). No adverse events associated with this product malfunction.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612186-2010-00006 |
| MDR Report Key | 1881977 |
| Report Source | 00,01,05,06 |
| Date Received | 2010-10-12 |
| Date of Report | 2010-10-12 |
| Date of Event | 2010-10-01 |
| Date Mfgr Received | 2010-09-26 |
| Date Added to Maude | 2010-11-17 |
| 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 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 806 |
| 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 | 2010-10-12 |
| Catalog Number | 1009622 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2010-10-12 |