LEKSELL STEREOTACTIC SYSTEM
Received Feb 28, 2018 · Event occurred Jun 30, 2017
Report 9612186-2017-00007 · MDR key 7302861
Device
Generic name
System, Radiation Therapy, Radionuclide
Manufacturer
Elekta Instrument AbProduct problems
- Fitting Problem
Patient
Unknown
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE MANUFACTURER'S INVESTIGATION IS ON-GOING AND FURTHER INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS COMPLETED. EMAIL ADDRESS UPDATED. ESTABLISHMENT NAME UPDATED. RESUBMITTING FORM 3500A DUE TO AN ADMINISTRATIVE ERROR. IT WAS REQUESTED BY FDA MEDWATCH PROGRAM DEPARTMENT TO RE-SUBMIT THE INITIAL REPORT AS THERE WAS NO RECORD OF INITIAL REPORT SUBMISSION IN EMDR SYSTEM. CORRECTION TICKED.
Description of Event or Problem
IT WAS REPORTED BY THE CUSTOMER THAT WHEN CARRYING OUT A SCANNER, THE LEKSELL SUPPORT FITS INTO THE EXAMINATION TABLE AT THE POINT WHERE THE SCANNER HEAD IS NORMALLY INSERTED. DURING THE MOBILISATION OF AN ANESTHETISED PATIENT, USERS WERE ABLE TO SEE THAT THE FIXATION SYSTEM OF THE LEKSELL SUPPORT AT THE EXAMINATION TABLE WAS NOT LOCKED, SO THE SUPPORT WAS MOBILISED WITH THE PATIENT.