MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2010-11-02 for LEKSELL STEROTACTIC SYSTEM manufactured by Elekta, Ltd..
[1765134]
When the doctor finished the treatment and take out the electrode, he found the tip of the electrode has adhesion with the patient's tissue. The customer bought the electrode in this august. It's just in use (less than 2 weeks). The setting for the lng is: temp: 80 degrees, time: 60s, power: 4-8p. The tissue adhesion lead to local bleeding nearby the operating area. Ct images shows that the bleeding is about 20 ml. The patient became drowsy, failed to use right side of his hand and leg. Failed to localize the problem. The doctor promised to return the electrode to elekta for further investigation once new one arrived.
Patient Sequence No: 1, Text Type: D, B5
[8869168]
The investigation into this situation is ongoing at this time. Once the investigation is completed, more details and a conclusion will be provided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612186-2010-00007 |
| MDR Report Key | 1942621 |
| Report Source | 07 |
| Date Received | 2010-11-02 |
| Date of Report | 2010-10-22 |
| Date of Event | 2010-09-28 |
| Date Mfgr Received | 2010-10-15 |
| Date Added to Maude | 2011-01-11 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer City | CRAWLEY, WEST SUSSEX |
| Manufacturer Country | UK |
| Manufacturer Phone | 293654250 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEKSELL STEROTACTIC SYSTEM |
| Generic Name | INSTRUMENT, STEREOTAXIC AND ACCESSORIES |
| Product Code | IWB |
| Date Received | 2010-11-02 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ELEKTA, LTD. |
| Manufacturer Address | CRAWLEY, WEST SUSSEX UK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-11-02 |