MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-08 for LEKSELL GAMMA KNIFE ICON manufactured by Elekta Instrument Ab.
[85766756]
The event has been resolved for the affected machine. Further investigation is ongoing.
Patient Sequence No: 1, Text Type: N, H10
[85766757]
During unloading of sources by elekta engineers, six sleeves came loose and later on when the emergency port had been opened, an additional six sleeves were also considered to be loose.
Patient Sequence No: 1, Text Type: D, B5
[133549952]
During initial loading of the cobalt sources of a gamma knife, loose source assembly lock rings were found. The lock rings were then put correctly into place on that particular machine before loading. However, an extra check during manufacturing was introduced in 2015 and this extra check is expected to detect any loose lock rings. Units manufactured after that date are therefore expected to be correct. The concerned machine was manufactured before that date. When analyzing the risks associated with loose lock rings, i. E. That source assemblies move out of position and affecting the delivered dose, it was found that the severity of the risk is a slight underdose (marginal) in correct position and that the probability is improbable (within acceptable region). The issues have been resolved for the affected machine and measures to check other machines due for installation or reload have already been implemented.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612186-2017-00010 |
| MDR Report Key | 6851232 |
| Date Received | 2017-09-08 |
| Date of Report | 2017-11-28 |
| Date of Event | 2017-08-12 |
| Date Mfgr Received | 2017-08-12 |
| Date Added to Maude | 2017-09-08 |
| 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 |
| 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 | 0 |
| Brand Name | LEKSELL GAMMA KNIFE ICON |
| Generic Name | SYSTEM, RADIATION THERAPY, RADIONUCLIDE |
| Product Code | IWB |
| Date Received | 2017-09-08 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2017-09-08 |