MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2009-09-01 for LEKSELL GAMMA KNIFE PERFEXION 6056 manufactured by Elekta Instrument Ab.
[1235997]
Customer received an initial position deviation error during treatment and could not clear it/proceed. Customer called the service engineer who explained how to clear the fault error message. The physicist cleared the fault error and continued the treatment. Later on in the same treatment, the customer received another initial position deviation error message. The treatment log indicated the customer cleared the fault error message again. Customer initiated a service call to evaluate the aps since it would not park properly (unless in trunnion mode). The aps position deviation resulted in a treatment misadministration up to 5 mm from the desired target.
Patient Sequence No: 1, Text Type: D, B5
[8283083]
Investigation results: the service engineer inspected the aps after treatment was completed (the aps wouldn't park properly). Found the l & r x-axis was reading greater by about 4-4. 5 mm from the digital reading of 100. Noticed on the treatment log error there was an apsm scale jump occurred during the treatment that night. Tried parking the mechanics and performing qa test run set-ups, but it would not move less than 104 on both mechanics. Scheduled future precise tool calibration of aps. Customer treated in trunnion mode until test tools are received. Current user manual contains instructions for accepting the position deviation error. An update of the user manual instructions for use will be made to further explain the consequence if user bypasses this error. This is a preventative measure to provide more info to the users.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612186-2009-00013 |
| MDR Report Key | 1495355 |
| Report Source | 05,06 |
| Date Received | 2009-09-01 |
| Date of Report | 2009-09-01 |
| Date of Event | 2009-08-10 |
| Date Mfgr Received | 2009-08-11 |
| Date Added to Maude | 2009-12-08 |
| 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 | STOCKHOLM |
| Manufacturer Country | SW |
| Manufacturer Phone | 293654250 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEKSELL GAMMA KNIFE PERFEXION |
| Generic Name | SYSTEM, RADIATION THERAPY, RADIONUCLIDE |
| Product Code | IWB |
| Date Received | 2009-09-01 |
| Model Number | 6056 |
| 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 | STOCKHOLM SW |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-09-01 |