MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2010-06-15 for LEKSELL GAMMA KNIFE MODEL 4C NA manufactured by Elekta Instrument Ab.
[1408653]
After removing a helmet from the machine and carrier, the customer was lowering the helmet changer in preparation for picking up the next helmet, the changer-lifter (without a helmet attached) suddenly dropped to the helmet from the mid point of its downward motion resulting in a bang.
Patient Sequence No: 1, Text Type: D, B5
[8621742]
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 | 9612186-2010-00003 |
| MDR Report Key | 1729837 |
| Report Source | 07 |
| Date Received | 2010-06-15 |
| Date of Report | 2010-06-14 |
| Date of Event | 2010-05-14 |
| Date Mfgr Received | 2009-06-02 |
| Date Added to Maude | 2011-02-22 |
| 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 | 93654250 |
| 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 | 2010-06-15 |
| 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 | 2010-06-15 |