PHASTIPP RESECTOR HANDPIECE

Additional Manufacturer Narrative

THE DEVICE WAS NOT RECEIVED FOR INVESTIGATION. THEREFORE, WE COULD NOT CONCLUSIVELY DETERMINE THE ROOT CAUSE OF THE REPORTED INCIDENT. 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 PRODUCTION AND TRACEABILITY RECORD FOR THE DEVICE WAS REVIEWED; NO ISSUES WERE FOUND DURING MANUFACTURING OR PACKAGING THAT WOULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. ALL QUALITY CONTROL TESTS WERE COMPLETED SUCCESSFULLY AND MET SPECIFICATION.

Description of Event or Problem

IT WAS REPORTED THAT BLOOD ENTERED PHASTIPP RESECTOR HANDPIECE DURING A PHLEBECTOMY PROCEDURE. THE DEVICE WAS CHECKED PRIOR TO USE. IT WAS NOTICED AFTER THE PROCEDURE. NO PATIENT INJURY WAS REPORTED.