MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-03-08 for LEKSELL GAMMA KNIFE ICON manufactured by Elekta Instrument Ab.
[69325614]
An investigation has been carried out, the outcome findings show an error was made during the installation of the device. The issue has been corrected by trained elekta operatives allowing the device to be returned to clinical use.
Patient Sequence No: 1, Text Type: N, H10
[69325615]
During installation of leksell gamma knife icon it was identified by an elekta installation engineer that some of the internal wiring was not connected correctly. The device is not in clinical use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612186-2017-00001 |
| MDR Report Key | 6386755 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-03-08 |
| Date of Report | 2017-03-08 |
| Date Mfgr Received | 2017-02-07 |
| Date Added to Maude | 2017-03-08 |
| 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 ICON |
| Generic Name | SYSTEM, RADIATION THERAPY, RADIONUCLIDE |
| Product Code | IWB |
| Date Received | 2017-03-08 |
| Operator | SERVICE PERSONNEL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| 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 | 2017-03-08 |