MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05,06 report with the FDA on 2013-06-17 for LEKSELL GAMMA KNIFE 4C manufactured by Elekta Instrument Ab.
[3543954]
A patient was undergoing a second gamma knife treatment on (b)(6) 2013 when the treatment was delivered to the wrong side of the brain.
Patient Sequence No: 1, Text Type: D, B5
[10785258]
The investigation into this incident is on-going at this time. Once the investigation is complete, elekta will forward additional information to the fda.
Patient Sequence No: 1, Text Type: N, H10
[10982228]
The manufacturer's investigation concluded that it was apparent that the plan and the verification were completed incorrectly by the responsible clinicians. The equipment performed as intended during planning and treatment. Please note that this is the final report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612186-2013-00004 |
| MDR Report Key | 3172544 |
| Report Source | 00,05,06 |
| Date Received | 2013-06-17 |
| Date of Report | 2013-07-31 |
| Date of Event | 2013-05-17 |
| Date Mfgr Received | 2013-06-07 |
| Date Added to Maude | 2013-06-17 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | LINAC HOUSE FLEMMING WAY |
| Manufacturer City | CRAWLEY, WEST SUSSEX RH109RR |
| Manufacturer Country | UK |
| Manufacturer Postal | RH10 9RR |
| Manufacturer G1 | ELEKTA INSTRUMENT AB |
| Manufacturer Street | P.O. BOX 7593 |
| Manufacturer City | STOCKHOLM, SE-103 9 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | SE-103 93 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEKSELL GAMMA KNIFE 4C |
| Generic Name | SYSTEM, RADIATION THERAPY, RADIONUCLIDE, |
| Product Code | IWB |
| Date Received | 2013-06-17 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ELEKTA INSTRUMENT AB |
| Manufacturer Address | P.O. BOX 7593 STOCKHOLM, SE-103 9 SW SE-103 93 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-06-17 |