DERMATOME AN HANDPIECE

Description of Event or Problem

IT WAS REPORTED THAT OUTSIDE OF SURGERY, THE UNIT NEEDED TO BE CALIBRATED. IT WAS NOT CUTTING PROPERLY; THE SKIN WAS TOO THICK. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

Additional Manufacturer Narrative

AN INVESTIGATION INTO THE REPORTED EVENT HAS BEEN INITIATED UNDER (B)(4). ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW UP REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS AND ANY ACTIONS TAKEN BY THE MANUFACTURER. G2: FOREIGN - EVENT OCCURRED IN SPAIN.