MEGADYNE

Additional Manufacturer Narrative

END USER REPORTED THAT THERE WAS CURRENT "LEAKING" THROUGH THE INSULATION. WE EVALUATED THE RETURNED SAMPLE. THERE WERE CLEAR INDICATIONS THAT THE DEVICE HAD BEEN MISUSED. THERE WAS EVIDENCE THAT THE ELECTRODE HAD NOT BEEN FULLY INSERTED INTO THE HANDPIECE WHICH IS CAUTIONED AGAINST IN THE PRODUCT IFU. THIS IS SEEN BY RESIDUE FROM AND ALTERNATE CURRENT ROUTE. ALSO, THERE ARE MARKS IN THE INSULATION FROM THE USE OF SOME TYPE OF CLAMPING INSTRUMENT WHICH DAMAGED THE INSULATION SHOWED SIGNS OF RESIDUE MEANING THE DAMGE WAS DONE BEFORE THE DEVICE WAS USED. THIS IS CAUTIONED AGAINST IN OUR IFU. THE INSULATION WAS ALSO COMPRESSED ON THE DEVICE. WE CONCLUDE THAT THE DEVICE WAS USED BEYOND THE SCOPE OF THE DESIGN OF THE PRODUCT AND CONTRARY TO THE IFU FOR THE PRODUCT. THIS REPORT WAS INITIALLY RECEIVED AS A PROBLEM WITH THE INSULATION. WE DID NOT BECOME AWARE OF THE PATIENT INJURY UNTIL 12/02/2016.

Description of Event or Problem

PER CUSTOMER: THE SURGEON NOTICED THAT TISSUE NEXT TO THE INSULATED PART OF THE SURGICAL TIP WAS BEING AFFECTED BY THE DIATHERMY, IMMEDIATELY UPON OPERATING. TISSUE NEXT TO THE INSULATED PORTION OF THE MEGAFINE TIP WAS DAMAGED DUR TO WHAT APPEARED TO BE CURRENT "LEAKING" THROUGH THE INSULATION. THE SURGEON WAS REQUIRED TO MAKE AN ADDITIONAL SUTURE, LEAVING THE PATIENT WITH AN ADDITIONAL SCAR.