STANDARD LEVEEN ELECTRODE
Received Mar 5, 2009 · Event occurred Nov 7, 2006
Report 3005099803-2008-02671 · MDR key 1333547
Device
Generic name
Electrode, Electrosurgical
Manufacturer
Boston Scientific Corporation-spencerModel number
M001262170Catalog number
26-217
Product problems
- Other (for use when an appropriate device code cannot be identified)
Patient
Not reported
- Burn(s)
Narrative
Description of Event or Problem
NOTE: THIS MFR REPORT PERTAINS TO THE SECOND OF TWO DEVICES THAT WERE USED DURING THE SAME PROCEDURE. REFER TO ASSOCIATED MFR REPORT #6000037-2006-00095 FOR A DESCRIPTION OF THE OTHER DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STANDARD LEVEEN ELECTRODE WAS USED DURING A TUMOR ABLATION PROCEDURE PERFORMED IN 2006 (FEMALE PATIENT; AGE AND WEIGHT ARE UNKNOWN). ACCORDING TO THE COMPLAINANT, THE PATIENT RECEIVED A SECOND DEGREE BURN ON HER THIGH DURING THE PROCEDURE. THEY FINISHED THE PROCEDURE WITH THE SAME ITEM. PATIENT IS FINE AND WAS DISCHARGED FROM THE HOSPITAL.
Additional Manufacturer Narrative
THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE SERIAL NUMBER; THEREFORE, THE DEVICE MANUFACTURE DATE IS UNKNOWN. ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED AND IS NOT AVAILABLE FOR RETURN. A DEVICE EVALUATION CANNOT BE PERFORMED; THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED.