MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,07 report with the FDA on 2011-04-05 for LEKSELL GAMMA KNIFE MODEL 4C NA manufactured by Elekta Instrument Ab.
[1940353]
On (b)(6) 2011, the physicist was trying to get the helmet hoist to lock on the helmet. The hoist down position sensor was failing, so the helmet was not locking. He reported that the hoist was not going to the fully up position also. While trying to drive the hoist down, without a helmet, the actuator snapped, failed, and subsequently caused the helmet hoist to break at the pivot point. The cartridge assy white block snapped around the pivots and fell to the ground.
Patient Sequence No: 1, Text Type: D, B5
[9063711]
Investigation is on-going so f/u reporting to this mdr will be provided to fda upon completion.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612186-2011-00002 |
| MDR Report Key | 2063796 |
| Report Source | 00,07 |
| Date Received | 2011-04-05 |
| Date of Report | 2011-04-04 |
| Date of Event | 2011-03-21 |
| Date Mfgr Received | 2009-06-02 |
| Date Added to Maude | 2011-07-20 |
| 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 | 2011-04-05 |
| 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 | 2011-04-05 |