PHASTIPP DISPOSABLE RESECTOR

Additional Manufacturer Narrative

THE DEVICE HAS NOT BEEN RECEIVED FOR INVESTIGATION. THEREFORE, WE COULD NOT CONCLUSIVELY DETERMINE THE ROOT CAUSE OF THE REPORTED INCIDENT. PER THE IFU: "POSITION THE DEVICE TO HOLD THE SHAFT UP AND THE HANDLE DOWN. WHILE CONTINUING TO HOLD THE SHAFT WITH ONE HAND, THE STERILE NURSE USES ANOTHER HAND TO GENTLY APPLY TENSION TO THE PULL TAB TO DEPLOY THE MICROBIAL BARRIER SHEATH OVER THE RESECTOR HANDPIECE. USE CARE NOT TO TOUCH THE NON-STERILE RESECTOR HANDPIECE. CONTINUE PULLING THE MICROBIAL BARRIER SHEATH UNTIL IT IS FULLY DEPLOYED AND THE TEAL HUB ON THE DISPOSABLE RESECTOR IS NO LONGER UNDER THE SHEATH. WITH THE MICROBIAL BARRIER SHEATH IN PLACE, THE ENTIRE DEVICE MAY NOW BE PLACED IN THE STERILE FIELD. USE CAUTION WHEN HANDLING THE DEVICE AND MICROBIAL BARRIER SHEATH. IF THERE IS ANY REASON TO SUSPECT THAT THE SHEATH IS DAMAGED OR COMPROMISED, IMMEDIATELY STOP AND REPLACE THE RESECTOR. 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. WE HAVE NOT RECEIVED ANY OTHER COMPLAINTS OF A SIMILAR NATURE FOR DEVICES FROM THIS LOT.

Description of Event or Problem

IT WAS REPORTED THAT DURING PROCEDURAL SETUP, THE PHASTIPP DISPOSABLE RESECTOR MICROBIAL SHEATH TORE WHILE BEING ADVANCED OVER THE HANDPIECE. THE TEAR OCCURRED AS THE USER PULLED THE SHEATH DOWN TO FULLY COVER THE HANDPIECE. AS A RESULT, THE INTEGRITY OF THE STERILE BARRIER WAS COMPROMISED, RENDERING THE DEVICE UNUSABLE SINCE THE NON-STERILE HANDPIECE MAY HAVE CONTAMINATED THE STERILE FIELD. A SECOND RESECTOR WAS OPENED TO CONTINUE THE PROCEDURE. THE AFFECTED DEVICE WAS NOT USED ON THE PATIENT. NO PATIENT INJURY OR ADVERSE CLINICAL OUTCOME WAS REPORTED.