MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2009-06-18 for LEKSELL GAMMA KNIFE 4C NA manufactured by Elekta Instrument Ab.
[16720251]
During patient treatment the hospital staff drew the helmet carrier to the helmet lock position, striking the patient in the head. The wound was approximately 1 centimeter and required one staple to close. A ct scan showed no further injuries to the patient.
Patient Sequence No: 1, Text Type: D, B5
[17053696]
Investigation results: no device malfunction occurred during this event. While completing the helmet changing actions, the hospital staff left the patient in the aps and the couch was not fully moved out. This is in contradiction to the user instructions provided with the leksell gamma knife where the patient must be removed from the equipment during helmet changes. User did not follow instructions.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612186-2009-00010 |
| MDR Report Key | 1405137 |
| Report Source | 07 |
| Date Received | 2009-06-18 |
| Date of Report | 2009-06-18 |
| Date of Event | 2009-06-01 |
| Date Mfgr Received | 2009-06-02 |
| Date Added to Maude | 2009-06-25 |
| 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 | 2009-06-18 |
| 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 | 1. Other | 2009-06-18 |