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Patient 1
THE PATIENTS EXACT AGE WAS NOT REPORTED, HOWEVER THE PATIENT WAS REPORTED TO BE OVER THE AGE OF 18. (B)(4). THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. HOWEVER, THE COMPLAINANT REPORTED THAT THE DEVICE WAS NOT EXPIRED. THE HEALTH CARE FACILITY ADDRESS IS (B)(6). (B)(4). INVESTIGATION RESULTS: A CELLEBRITY CYTOLOGY BRUSH WAS RETURNED FOR EVALUATION. A VISUAL ANALYSIS OF THE RETURNED DEVICE REVEALED THAT IT HAD SHEATH DAMAGE. IT WAS RECEIVED IN CLOSED/RETRACTED POSITION AND THE YELLOW SHEATH WAS DETACHED FROM THE HANDLE AND ITS PROXIMAL SECTION WAS TORN. THERE WERE NO OTHER ANOMALIES NOTED. A FUNCTIONAL INSPECTION WAS PERFORMED AND FOUND THAT THE BRUSH COULD NOT BE OPENED/EXTENDED PROBABLY DUE TO THE SECTION OF THE SHEATH FOUND DAMAGED (DETACHED AND TORN).THE FAILURE FOUND (YELLOW SHEATH DETACHED AND TORN) IS AN ISSUE THAT COULD HAVE BEEN GENERATED BY EXCESSIVE MANIPULATION OF THE DEVICE BY THE USER AND/OR EXCESS OF FORCE APPLIED TO THE PRODUCT; ONCE THE SHEATH HAS BEEN DAMAGED IT WILL AFFECT THE FUNCTIONALITY OF THE DEVICE SINCE THIS TYPE OF DEFECT DOES NOT ALLOW THE DEVICE TO PERFORM ITS FUNCTION TO MOVE BACKWARD / FORWARD AS IS EXPECTED; HENCE, THE BRUSH SECTION CANNOT BE EXTENDED OR RETRACTED PROPERLY. THEREFORE, IT WAS CONCLUDED THAT THE INVESTIGATION CONCLUSION CODE FOR THIS EVENT IS "CAUSE TRACED TO COMPONENT FAILURE" SINCE THE FAILURE WAS AN EXPECTED OR RANDOM COMPONENT FAILURE WITHOUT ANY DESIGN OR MANUFACTURING ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND CONFIRMED THAT THIS DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS AT THE TIME OF RELEASE FOR DISTRIBUTION.