UROPASS AS 12/14FR X 54 CM 5/BX

Additional Manufacturer Narrative

THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO REPORT THE ORIGINAL EQUIPMENT MANUFACTURER (OEM) DEVICE EVALUATION RESULTS. THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION. THIS DEVICE IS MANUFACTURED BY TELEFLEX A THIRD PARTY VENDER THAT CANNOT EXCEPT FIELD DEVICES AND REQUIRES PHOTOS INSTEAD FOR THE COMPLAINT INVESTIGATION. THE OEM PERFORMED A PHOTOGRAPHIC EVALUATION AND FOUND THE DILATOR BROKEN INTO 3 PIECE (TIP PIECE MISSING MATERIAL). A DHR REVIEW REVEALED THAT THE PRODUCT MET SPECIFICATIONS AT THE TIME OF MANUFACTURING. THE REFERENCED LOT NUMBER WAS MANUFACTURED IN NOVEMBER 2012. THE OEM PREFORMED A COMPLAINT HISTORY REVIEW FOR THE SUBJECT DEVICE AND FOUND THAT OF ALL THE UNITS SHIPPED IN 2012 THIS IS THE SECOND KNOWN OCCURRENCE OF A DILATOR BREAK FROM THAT YEAR. IT WAS ALSO NOTED THAT THIS COMPLAINT OCCURRED 5 MONTHS BEFORE THE EXPIRATION DATE OF NOVEMBER 2017. BASED ON SIMILAR REPORTS BETWEEN OCTOBER 2010 AND JUNE 2013, THE ROOT CAUSE FOR THE REPORTED EVENT IS SUBSTANTIAL LIGHT EXPOSURE OF THE DEVICES IN THE HEALTH CARE FACILITY, WHICH RESULTED IN DEGRADATION AND EMBRITTLEMENT OF THE DILATOR POLYMER. SINCE THERE IS NO TELEFLEX MANUFACTURING, MATERIAL, OR PROCESS RELATED CAUSE FOR THIS FAILURE MODE NO FURTHER ACTION IS REQUIRED.

Additional Manufacturer Narrative

THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THE CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED AT THIS TIME.

Description of Event or Problem

OLYMPUS WAS INFORMED THAT DURING UNSPECIFIED PROCEDURE, THE SHEATH BROKE OFF AND FELL INSIDE THE PATIENT. IT IS UNKNOWN IF DEVICE FRAGMENTS WERE RETRIEVED. IT IS UNKNOWN IF THE INTENDED PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INJURY REPORTED.