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 2012-05-30 for LEKSELL GAMMA KNIFE 4C NA manufactured by Elekta Instrument Ab.
[2785436]
Customer reports data is missing from the treatment protocol printout. It is unknown at this time whether this could have led to an adverse event. Initial assessment shows that there may be a risk that too much radiation could have been given.
Patient Sequence No: 1, Text Type: D, B5
[9828849]
The investigation into this situation is on-going at this time. Once the investigation has been completed, more details and a conclusion will be provided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612186-2012-00002 |
| MDR Report Key | 2602504 |
| Report Source | 00,05,06 |
| Date Received | 2012-05-30 |
| Date of Report | 2012-05-30 |
| Date of Event | 2012-05-02 |
| Date Added to Maude | 2012-08-03 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | KUNGSTENSGATAN 18 |
| Manufacturer City | STOCKHOLM |
| Manufacturer Country | SW |
| Manufacturer Phone | 293654250 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEKSELL GAMMA KNIFE |
| Generic Name | SYSTEM, RADIATION THERAPY, RADIONUCLIDE |
| Product Code | IWB |
| Date Received | 2012-05-30 |
| Model Number | 4C |
| Catalog Number | NA |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| 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 STOCKHOLM SW |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-05-30 |