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 4C NA manufactured by Elekta Instrument Ab.
[1940835]
During a helmet change, the helmet changer drive actuator separated from the helmet changer. The separation occurred at the upper bracket of the helmet changer and the top of the shaft of the linear actuator. It appeared that the upper attachment point of the linear actuator unscrewed, separating it from the actuator drive shaft. The helmet changer fell a very short distance as they were about to do a helmet change on the trolley. The customer was having an issue where the helmet would not unlock onto the trolley. This was probably due to the switch and sensor not both being activated at the same time. The upper coupling was unscrewing and as such both sensors were not activating simultaneously. No one was injured but the customer heard a loud sound when the helmet fell the short distance to the helmet trolley.
Patient Sequence No: 1, Text Type: D, B5
[9061015]
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 | 9612186-2011-00001 |
| MDR Report Key | 2063816 |
| Report Source | 00,07 |
| Date Received | 2011-04-05 |
| Date of Report | 2011-04-04 |
| Date of Event | 2011-03-14 |
| Date Mfgr Received | 2009-06-02 |
| Date Added to Maude | 2011-05-11 |
| 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 | PHYSICIST |
| 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 | 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 |