MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2010-03-01 for LEKSELL GAMMA KNIFE MODEL 4C NA manufactured by Elekta Instrument Ab.
[1288674]
The customer reports that while attempting to perform a qa test run, the qa test tool fitted in the mechanics fell out onto the table and left aps y axis fell below its scaled limit of 160. Service engineer arrived on site and confirmed that the scale had travelled beyond its limit of 160 and was resting on the angled portion of the flex cover but was able to manually drive the y axis to within normal range. However, because of reliability, the mechanics could not be determined nor could determine the cause of the problem, replacement of mechanics and computer was performed.
Patient Sequence No: 1, Text Type: D, B5
[8456407]
Investigation is on-going so follow-up reporting to this mdr will be provided to fda upon completion.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612186-2010-00002 |
| MDR Report Key | 1627165 |
| Report Source | 07 |
| Date Received | 2010-03-01 |
| Date of Report | 2010-03-01 |
| Date of Event | 2010-01-22 |
| Date Mfgr Received | 2009-06-02 |
| Date Added to Maude | 2011-03-09 |
| 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 | KUNGSTENSGATAN 18 |
| Manufacturer City | STOCKHOLM |
| Manufacturer Country | SW |
| Manufacturer Phone | 293654250 |
| Single Use | 3 |
| Remedial Action | IN |
| 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 | 2010-03-01 |
| Model Number | MODEL 4C |
| Catalog Number | NA |
| Lot Number | NA |
| 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 | KUNGSTENSGATAN 18 STOCKHOLM SW |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-03-01 |