MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2013-12-10 for LEKSELL GAMMA KNIFE PERFEXION manufactured by Elekta Instrument Ab.
[3966600]
Elekta identified a report on asn website referring to a patient mistreatment. Treatment delivered to the wrong side. When writing the report at the end of exposure, radiation therapist found that the treatment had been delivered to the wrong side. This error is the result of an error in treatment planning. The patient has been informed and is under health monitoring. The analysis of this event conducted by the unit radiosurgery and radiotherapy showed that, in the case of this specific pathology, the medical imaging did not allow to differentiate the healthy area of the area to be treated. The radiosurgery unit has already implemented corrective actions to avoid duplication of this type of error including the integration of the side to be treated in the checklist, staff training on new tool and reminder of audit procedures.
Patient Sequence No: 1, Text Type: D, B5
[11301189]
The manufacturer's device was identified in a government nuclear agency report published on their website. The customer has not contacted the manufacturer. This is the manufacturer's final report. Customer has not contacted elekta.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612086-2013-00009 |
| MDR Report Key | 3511222 |
| Report Source | 00 |
| Date Received | 2013-12-10 |
| Date of Report | 2013-12-10 |
| Date Mfgr Received | 2013-11-29 |
| Device Manufacturer Date | 2010-08-10 |
| Date Added to Maude | 2013-12-12 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEKSELL GAMMA KNIFE PERFEXION |
| Generic Name | RADIONUCLIDE RADIATION THERAPY SYSTEM |
| Product Code | IWB |
| Date Received | 2013-12-10 |
| Operator | HEALTH PROFESSIONAL |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ELEKTA INSTRUMENT AB |
| Manufacturer Address | KUNGSTENSGATAN 18, P.O. BOX 759 STOCKHOLM, SE-103 9 SW SE-103 93 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-12-10 |