PHASTIPP RESECTOR HANDPIECE

Additional Manufacturer Narrative

THE DEVICE WAS RECEIVED FOR INVESTIGATION. BLOOD WAS CONFIRMED IN THE RESECTOR HANDPIECE. MANUFACTURING ATTEMPTED TO RECREATE THE ISSUED WHILE TESTING BUT WAS UNABLE TO REPRODUCE THE FAILURE FOR 3 DIFFERENT LOTS OF FINISHED GOODS. IT IS LIKELY THAT THE ISSUE IS DUE TO THE USE/SETUP AT THE SITE. HOWEVER, THE EXACT ROOT CAUSE COULD NOT BE DETERMINED. THE LOT HISTORY RECORD FOR THE DEVICE WAS REVIEWED, NO ISSUES WERE FOUND DURING MANUFACTURING OR PACKAGING THAT WOULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. WE HAVE NOT RECEIVED ANY SIMILAR COMPLAINTS RELATED TO THIS LOT NUMBER.

Description of Event or Problem

IT WAS REPORTED THAT IT WAS DIFFICULT TO CONNECT THE PHASTIPP ILLUMINATOR HANDPIECE TO THE PHASTIPP RESECTOR HANDPIECE. THE RESECTOR WAS REPORTED TO BE COLLECTING BLOOD ON THE HANDPIECE IN THE CLEAR PLASTIC SHEATH AND ENTERING THE NON-STERILE, RE-USABLE DEVICE DURING A VARICOSE VEIN REMOVAL PROCEDURE. NO INJURY WAS REPORTED TO THE PATIENT.