URO-GUIDE,6.0 X 22 CM WO/GW

Additional Manufacturer Narrative

THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. CORRECTION: D9 -THE SUBJECT DEVICE FOR THIS COMPLAINT WAS NOT RETURNED ADDITIONAL INFORMATION: H6, H11 A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, AND SINCE THE SUBJECT DEVICE WAS NOT RETURNED FOR EVALUATION, THE DEFINITIVE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

Description of Event or Problem

IT WAS REPORTED THAT THE URETERAL STENT IMPLANTED AND REMAINED IN PATIENT OVER TIME CAUSED ¿SLIPPAGE¿ AND PATIENT DISCOMFORT. THERE WAS NO MEDICAL INTERVENTION OR ADDITIONAL PROCEDURE REQUIRED DUE TO STENT MIGRATION. THERE IS NO EVIDENCE THAT A LIFE-THREATENING EVENT OCCURRED, THAT THE PATIENT DEVELOPED PERMANENT DAMAGE OR IMPAIRMENT, OR THAT ADDITIONAL MEDICAL/SURGICAL INTERVENTION WAS DONE TO PREVENT PERMANENT DAMAGE OR IMPAIRMENT. THE ISSUE WAS FOUND DURING A STENT PLACEMENT PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

Additional Manufacturer Narrative

THE DEVICE EVALUATION IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.