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Patient 1
THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. OLYMPUS FOLLOWED UP WITH THE USER FACILITY VIA TELEPHONE AND IN WRITING TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT BUT WITH NO RESULT. THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED AT THIS TIME. HOWEVER, THE INSTRUCTION MANUAL PROVIDES USERS WITH SEVERAL WARNINGS TO HELP PREVENT DAMAGE TO THE URETERAL ACCESS SHEATH: WARNING AND CAUTION SECTION PG. 2: DO NOT INSERT THIS DEVICE IF IT HAS BEEN KINKED OR DAMAGED PRIOR TO USE?REPLACE WITH UNDAMAGED PRODUCT. AVOID CONTACT WITH SHARP OBJECTS AS THE DEVICE CAN BE EASILY NICKED, THEREBY INCREASING THE POTENTIAL FOR BREAKAGE. SECTION 4.0 SECTION 4.0 INSPECTION PG. 6: DO NOT USE THE PRODUCT UNLESS IT IS IN THE ORIGINAL, INTACT PACKAGING. INSPECT THE DEVICE FOR ANY EVIDENCE OF KINKS, NICKS, TEARS, OR CRACKS THAT MIGHT HAVE OCCURRED IN THE DELIVERY OF THE DEVICE TO THE STERILE FIELD. DO NOT USE A DAMAGED PRODUCT. SECTION 5.0 SUGGESTED PROCEDURE PG. 8: PRIOR TO USE, SEPARATE THE DILATOR AND SHEATH AND PLACE INTO A CONTAINER OF SALINE OR STERILE WATER FOR APPROXIMATELY 15 SECONDS TO ACTIVATE THE HYDROPHILIC COATING. RE-WET AS NECESSARY. ADVANCE THE DILATOR/SHEATH ASSEMBLY OVER THE GUIDEWIRE TO THE DESIRED LOCATION. IF RESISTANCE IS ENCOUNTERED, STOP! DO NOT ADVANCE AGAINST RESISTANCE. DAMAGE TO THE ANATOMY COULD RESULT. ONCE POSITIONED, GRASP AND SQUEEZE THE DILATOR CLIP THUMB TABS TO RELEASE THE DILATOR FROM THE SHEATH FUNNEL AND GENTLY WITHDRAW THE DILATOR, WHILE MAINTAINING SHEATH POSITION. DO NOT ADVANCE THE SHEATH WITHOUT THE DILATOR IN PLACE.