MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,06,07 report with the FDA on 2014-11-27 for LEKSELL GAMMA KNIFE PERFEXION WITH EXTEND FRAME SYSTEM manufactured by Elekta Instrument Ab.
[5224069]
The customer reported that the extend front piece was broken. When they tried to detach the extend front piece from the patient after treatment, the parts of extend front piece were detached from the extend body. There were not sure when parts became loose.
Patient Sequence No: 1, Text Type: D, B5
[12587432]
The extend bottom plate broke during usage. The customer has used the equipment for (b)(4) cases without any problems. The customer sterilized the parts using ethylene oxide gas. It is probable that the root cause of the problem is the sterilization procedure (user error). The parts have not been returned to the manufacturer for investigation. In the manufacturer's instructions for use there are two warnings that the equipment should not be sterilized since it may change the product and that the products shall not be used when damaged. Information provided by the customer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612186-2014-00008 |
| MDR Report Key | 4282825 |
| Report Source | 00,06,07 |
| Date Received | 2014-11-27 |
| Date of Report | 2014-11-27 |
| Date of Event | 2014-10-29 |
| Date Mfgr Received | 2014-10-29 |
| Date Added to Maude | 2014-12-04 |
| 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 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| 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 | 2014-11-27 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ELEKTA INSTRUMENT AB |
| Manufacturer Address | PO BOX 7593 STOCKHOLM, SE103 93 SW SE103 93 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-11-27 |